[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tata Memorial Centre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":657},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,45,77,105,128,156,178,202,230,256,282,309,337,367,390,417,445,474,502,524,545,568,590,609,631],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100553930","phase-2-glioma-adaptive-radiotherapy-with-development-of-an-artificial-intelligence-workflow-100553930",false,"NCT06492486","Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow","GLADIATOR","Inclusion Criteria:\n\n* Histological diagnosis of diffuse glioma. Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) need radiotherapy (stratum B).\n\nAge: 18-70 years. Karnofsky Performance Scale (KPS) ≥60\n\nExclusion Criteria:\n\n* Multifocal or multicentric disease Not eligible for radical intent radiation. IDH status is unknown or uninterpretable (IHC or gene sequencing). Use of prior radiotherapy to the head-neck region or brain or chemotherapy. Contraindication\u002Funable to undergo MRI or PET scan during radiation.","ALL","18 Years","70 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Gliomas are common primary brain tumors in adults. Gliomas can be classified into different types based on tumor grade, histopathological features, and molecular characteristics. The common types of diffuse gliomas include glioblastoma, astrocytoma, and oligodendroglioma. The standard treatment for diffuse gliomas includes surgery followed by radiation and chemotherapy. As per standard institutional practice, a uniform dose of radiation is delivered to the disease area and MRI is done before and after the treatment. In this study, MRI and PET scan will be done before starting the treatment and standard dose of radiation will be delivered. The interval imaging will be done twice during the course of treatment with MRI and PET, followed by dose modifications. The CT, MRI, and PET will be combined. Based on PET imaging, specific dose will be altered and delivered to specific areas. Dose modification will be done with the help of artificial intelligence. Participant's assessment will be done at regular intervals.\n\nModifications in radiation plans are done based on the changes in disease seen in scans is likely to improve the accuracy of RT treatments. Dose modifications based on imaging to resistant areas will help achieve better tumor control, reduce treatment-related toxicities, precise delivery of the RT and adjusting doses to the organs at risk (OAR) and changes in disease leading to better treatment compliance. Creating an artificial intelligence framework in radiation oncology promises to improve quality of workflow, treatment planning and RT delivery.\n\nThe aim of the study is to develop an artificial intelligence workflow for treatment of glioma with adaptive radiotherapy. This study will be conducted in Tata Memorial Centre on a population of 60 patients for a duration of 2 years. The total study duration is 4 years.",[28,29,30,31],"Diffuse Glioma","Glioblastoma","Adaptive Radiotherapy","Artificial Intelligence","RECRUITING","2026-08-13",{"date":35,"type":36},"2026-08-17","ACTUAL",{"date":38,"type":36},"2026-07-27",{"date":40,"type":22},"2028-07-30",{"name":42,"class":43},"Tata Memorial Centre","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100647386","phase-2-chlorophyllin-for-reducing-oral-mucositis-in-total-body-irradiation-prior-to-transplant-100647386","NCT07709195","Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant","Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation","ChROMME-TBI","Inclusion Criteria\n\n* Patients ≥12 and ≤65 years of age\n* First allogeneic stem cell transplant\n* Total body irradiation dose (fractionated) ≥8 Gy\n\nExclusion Criteria\n\n* Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)","12 Years","65 Years",{"count":56,"type":22},17,[25],"The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT).\n\nThe main questions it aims to answer are:\n\nDoes oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety?\n\nParticipants will:\n\nReceive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT.\n\nUndergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care.\n\nHave regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD).\n\nProvide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.",[60,61,62,63],"Oral Mucositis","Total Body Irradiation","Hematological Malignancies","Hematopoietic Stem Cell Transplantation (HSCT)",[65,60,66,67,68,69,61],"Chlorophyllin","Allogeneic HSCT","Phase II Trial","Supportive Care","Acute Leukemia","2026-07-23",{"date":38,"type":36},{"date":73,"type":36},"2024-10-30",{"date":75,"type":22},"2027-03-05",{"name":42,"class":43},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100648730","phase-1-study-to-evaluate-the-safety-and-effectiveness-of-withaferin-a-as-a-treatment-to-prevent-gvhd-in-transplant-patients-100648730","NCT07724873","Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant Patients","A Phase I\u002FII Trial to Assess Safety and Activity of Standardized Withaferin A as GvHD Prophylaxis in Patients Undergoing Matched Related Donor Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. ECOG performance score of 0 or 1\n2. Adequate liver function (Total serum bilirubin \\\u003C twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 3-fold higher than laboratory upper normal limits)\n3. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n4. Adequate cardiac function (LVEF\\>40%)\n5. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.\n6. Signed, written informed consent\n\nExclusion Criteria: -\n\n1. Known hypersensitivity or contraindications against Withaferin-A.\n2. Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n3. Any medical or psychiatric illness which precludes the participant from giving informed consent\n4. Pregnancy, lactation, or inadequate contraception.",{"count":85,"type":22},54,[87,25],"PHASE1","What is acute Graft versus host disease (aGvHD)? GvHD is a complication that can occur after an allogeneic stem cell transplant resulting in damage to some organs. The death rate of GvHD patients is 15-40%. In GvHD, the donated peripheral blood stem cells or bone marrow view the recipient's body as foreign, and the donated cells\u002Fbone marrow harm the body. aGvHD usually develops in skin, liver or gastrointestinal tract, and symptoms might appear within few weeks after transplant. Symptoms of acute GvHD are observed as skin rash or reddened areas on the skin, yellow discoloration of the skin and\u002For eyes, and abnormal blood test results, nausea, vomiting, diarrhea, or abdominal cramping.\n\nWhat is the current prevention used for GvHD? To prevent development of GvHD many standard drugs like cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide are given.\n\nWhat is standardized Withaferin-A (SWA)? Withaferin-A (WA) is the main active component of Withania somnifera (Ashwagandha). It has been shown in many studies to have properties of healing and immune-modulation (improving the immune system). Studies have been done in our Clinical Pharmacology Laboratory that have shown a significant beneficial effect of this drug, when added to the standard drugs used for prophylaxis of GvHD, on reducing the risk of acute GvHD. The drug has also been tested and proven to be very safe in humans.\n\nWhat is the rationale of this trial? As has been described earlier, GvHD is a difficult complication of allogeneic stem cell transplant which can lead to increased hospital stay and deaths post-transplant. The standard drugs for prevention of GvHD are cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide. These drugs also have some side effects during the course of transplant. This points out the need for new preventive drugs that are safe and effective.\n\nSWA is an oral formulation of WA which seems to be beneficial in the early studies done in the Clinical Pharmacology Laboratory, ACTREC. SWA has also been found to be safe at very high doses.\n\nSWA will be given along with the standard drugs given to prevent GvHD. Despite of consuming these drugs, about 40 - 60% patients still develop GvHD. The investigators aim to add SWA to these standard drugs during transplant to reduce significant aGvHD.\n\nHow will SWA be given? Participants who agree to participate in this trial and are found to be eligible will be given SWA as a capsule at a dose of 500 mg\u002Fday (2 capsules of 250 mg) to 3000 mg\u002Fday (6 capsules of 250 mg) as per the dose level allotted to the Patient. The drug will be given for a total duration 90 days starting from Day +1 of transplant. All other standard treatments which are part of a transplant procedure will be carried out without any change.\n\nParticipants will be monitored clinically for any adverse events and followed up as per standard protocols post-transplant.\n\nWhat additional tests will be carried out? Additional blood sampling to study the levels of the drug WA blood samples will be collected at 0, 1, 2, 4, 8 hours on the day of start of SWA (Day +1) and Day +7. Checking immune cell profile and cytokines (which are markers of - immunity levels) will be done at Day+30, Day +90, Day+180, Day+365 from the start of SWA which is also the part of routine care. Blood sample of 5 ml will also be taken at Day 0, Day +14, Day +30, Day +60 and Day +90 after start of drug to see level of some special protein called JAK2 STAT3 protein.\n\nWhat are the risks involved in participation? According to available literature and information, SWA is a safe and well tolerated drug. In a phase 1 study, Standardized Withaferin-A was administered to Patients with advanced stage osteosarcoma. The drug was well tolerated by Patient up to a dose of 4800 mg. No severe side effects were observed. Increase in liver enzymes and skin rash were the most common side effects. Other side effects included fatigue, fever, swelling, and diarrhea.\n\nWhat is the possible impact of this trial? If indeed SWA works and prevents GvHD effectively then this could be a breakthrough in treatment. It would help many Pateints to prevent GvHD post allogeneic stem cell transplant and would be a safe, easily available, inexpensive and oral drug for the same. This possibly could benefit and help future Patients who undergo bone marrow transplant (BMT) to have better chances of survival and reduce their financial burden.",[90,91,92],"Hematopoietic Stem Cell Transplant (HSCT)","GVHD - Graft-Versus-Host Disease","Hematological Malignancy",[94,95],"Standardized Withaferin A","Matched related donor Hematopoietic stem cell transplant","2026-07-20",{"date":98,"type":36},"2026-07-24",{"date":100,"type":36},"2025-01-28",{"date":102,"type":22},"2029-12-03",{"name":42,"class":43},2,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":104},"100648325","phase-2-to-study-lower-dose-of-cyclophosphamide-after-stem-cell-transplant-for-blood-cancers-100648325","NCT07719946","To Study Lower Dose of Cyclophosphamide After Stem Cell Transplant for Blood Cancers","Phase II Trial of Reduced Dose Post Transplant Cyclophosphamide After Haploidentical Hematopoietic Stem Cell Transplant in Hematological Malignancies","Inclusion Criteria: -\n\n* Patients age ≥ 18 years\n* ECOG performance score of 0 or 1\n\nExclusion Criteria: -\n\n* Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Any medical or psychiatric illness which precludes the participant from giving informed consent.\n* Organ function criteria: Serious organ dysfunctions:\n* Serious cardiac dysfunction: Left ventricular ejection fraction \\\u003C 45%; no uncontrolled arrhythmias or symptomatic cardiac disease.\n* Serious pulmonary organ dysfunction: Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =\\\u003C 50% of predicted (corrected for haemoglobin).\n* Serious renal dysfunction: Measured serum creatinine clearance =\\\u003C 60 mL\u002Fmin.\n* Serious Hepatic dysfunction: Total serum bilirubin more than twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits.",{"count":113,"type":22},20,[25],"Cyclophosphamide is the name of a medicine given to prevent graft-versus-host-disease (GVHD) after half-matched transplant. This medicine is given on the 3rd and 4th day after stem cell transplant. The standard dose of this medicine is 50 mg per kg of the patient's weight given on the 3rd and the 4th day. However, using this medicine at this dose of 50 mg \u002F kg for 2 days is associated with certain problems such as susceptibility to infections and delay in the recovery of the immune system after stem cell transplant. Therefore, several research groups across the world have tried to reduce the dose of cyclophosphamide that is used. These groups have tried reducing the dose from 50 mg per kg to 25-40 mg per kg. These studies have shown that the reduced dose cyclophosphamide is equally effective in preventing GVHD. However, these studies are carried out on small numbers of patients and further studies are essential to confirm whether reduced dose of cyclophosphamide is equally effective. In this study, we will use cyclophosphamide at a lower dose (25 mg\u002Fkg x 2 days) and see if the lower dose results in equal efficacy but lesser toxicities This is a single-arm study. All participants will receive the same treatment; there is no comparison group.\n\nParticipants will:\n\nAdults (age ≥18) undergoing haploidentical stem cell transplant for blood cancers Receive low-dose cyclophosphamide (25 mg\u002Fkg\u002Fday) on Day 3 and Day 4 after transplant Also receive standard GVHD preventive medicines (calcineurin inhibitor and mycophenolate) Undergo regular blood tests, immune system monitoring, and GVHD assessments Have immune cell and cytokine profiles analyzed through blood samples",[117,62],"Haploidentical Hematopoietic Stem Cell Transplant",[119],"Low dose cyclosphosphamide","2026-07-17",{"date":122,"type":36},"2026-07-22",{"date":124,"type":36},"2025-03-26",{"date":126,"type":22},"2028-11-12",{"name":42,"class":43},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100647415","phase-2-leflunomide-to-prevent-cytomegalovirus-reactivation-in-stem-cell-transplant-patients-100647415","NCT07709013","Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients","Use of Leflunomide as Primary Prophylaxis Against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) - Single, Arm, Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Males or females undergoing Haplo-identical haematopoetic stem cell transplant.\n2. Age ≥18yrs on the day of signing informed consent\n3. Undetectable CMV from plasma sample in preceding 7 days\n4. Patient who has WBC engraftment (ANC\\>=500\u002Fcumm for 3 or more consecutive days).\n5. Within 7 days of WBC engraftment\n6. Adequate liver functions (ALT \u002F AST less than 5 times upper limit of normal and Bilirubin \\\u003C=3 times upper limit of normal) at time of starting leflunomide\n7. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to Leflunomide\n2. History of clinically significant CMV reactivation in past 1 year\n3. Patient is receiving\u002Fhas received drug known to have anti CMV activity within in last 7 days \\[Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir (at doses \\>=3200 mg PO per day or \\>=25 mg\u002Fkg IV per day), valacyclovir (at doses \\&\\>=3000 mg PO per day)\\]\n4. Inadequate renal function (creatinine clearance \\\u003C=30 ml\u002Fmin)\n5. Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or\u002Fand HIV\n6. Any psychiatric condition that might limit the ability of the patient to comply with the protocol",{"count":136,"type":22},22,[25],"Patients undergoing half-matched hematopoietic stem cell transplantation (HSCT) are at high risk of viral reactivation after bone marrow transplantation (BMT). The purpose of this study is to evaluate whether leflunomide can prevent cytomegalovirus (CMV) reactivation in these patients and to assess its safety.\n\nThe main questions it aims to answer are -\n\n1. Does leflunomide prevent cytomegalovirus (CMV) related organ damage?\n2. Does leflunomide prevent a rise in cytomegalovirus (CMV) copy number to more than 2000 copies\u002Fml?\n3. Does leflunomide prevent the need to start pre-emptive therapy for cytomegalovirus (CMV)?\n4. Is it safe to use in bone marrow transplant ( BMT) patients?\n5. Does leflunomide prevent other viral reactivations - like Adeno virus and BK virus?\n6. Does leflunomide affect the risk of acute graft-versus-host disease ( acute GVHD) after bone marrow transplant (BMT)?\n\nWhat medicine will the patients receive? Patients in study shall receive loading dose of Tab. Leflunomide 100 mg daily for 3 days followed by 20 mg daily orally. Leflunomide will be given till day +180 post transplant or till patient is on immunosuppressant medicines.",[140],"Hematologic Malignancies",[142,143,144,145,146],"Cytomegalovirus (CMV) Reactivation","Leflunomide","haplo-HSCT","Haploidentical","Hematopoietic stem cell transplant","2026-07-11",{"date":149,"type":36},"2026-07-16",{"date":151,"type":36},"2024-10-18",{"date":153,"type":22},"2029-04",{"name":42,"class":43},3,{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":44},"100647328","phase-2-study-of-standardized-withaferin-a-for-the-treatment-of-steroid-refractory-acute-graft-versus-host-disease-100647328","NCT07708987","Study of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease.","A Phase II Clinical Trial of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease","Withaferin_A","Inclusion Criteria:\n\n* Patients age ≥ 12 years with a hematological malignancy who have undergone allogeneic stem cell transplant with matched related donor (MRD), Haploidentical (Haplo) donor or matched unrelated donor (MUD)\n* Evidence of myeloid engraftment (eg, absolute neutrophil count ≥0.5 × 109 \u002FL for 3 consecutive days)\n* ECOG performance score of 0 or 1\n* Patients with steroid-refractory aGvHD, defined as any of the following:\n* Patients with progressive GvHD (ie, increase in stage in any organ system or any new organ involvement) after 3 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients with GvHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 7 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients who previously began corticosteroid therapy at a lower dose (≥1 mg\u002Fkg\u002Fd methylprednisolone) for treatment of skin GvHD or skin GvHD accompanied by upper gut GvHD but develop new GvHD in another organ system\n* Patients who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindications against Withaferin-A.\n* Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Any medical or psychiatric illness which precludes the participant from giving informed consent.",{"count":165,"type":22},34,[25],"Study Design Prospective, single center, single arm, Phase II study.\n\nResearch aims and objectives Aim:\n\nTo evaluate the efficacy and safety of standardized Withaferin A in steroid refractory acute GvHD in patients post allogeneic stem cell transplantation\n\nPrimary Objective:\n\nTo evaluate the objective Response Rate (ORR) at Day 28 from the start of SWA defined as the proportion of patients achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR).\n\nMethodology\n\nTreatment plan and Interventions Administration of study treatment Name of the intervention: Standardized WA (standardized root extract of Withania somnifera. This will be provided free of cost to the trial patients.\n\nFormulation: The standardized root extract of W. somnifera contains 5% of WA w\u002Fw. SWA is available as a 500 mg capsule (AshwaMAX) that contains 25 mg of WA.\n\nRoute of administration: Per-oral (P\u002FO) Dose schedule: The dose of SWA is 1500mg\u002Fday. It will be administered as 3 capsules of 500 mg once a day.\n\nDuration of treatment:\n\n* Every patient will receive treatment for at least 12 weeks followed by a taper as per physician's discretion. WA can be tapered after 12 weeks if the patient has achieved CR or VGPR and has discontinued corticosteroids for at least 4 weeks.\n* Dose adjustments\u002Fmodifications: If the patient experiences any grade ≥3 toxicities related to SWA, further administration of SWA will be withheld immediately. Once the severity of the adverse event reduces to grade ≤1, the study agent will be rechallenged with 25% dose reduction. The same strategy will be adopted for successive grade ≥3 toxicities. If the drug is not tolerated at 25% of original dose (100 mg), no further rechallenge will be attempted.\n* Corticosteroid tapering will be done as per the treating physician's discretion and clinical condition of the patient.",[92,91,169],"Steriod Refractory",[171],"Withaferin A",{"date":149,"type":36},{"date":174,"type":36},"2023-09-23",{"date":176,"type":22},"2028-09-25",{"name":42,"class":43},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":44},"100618970","bio-short-hypofractionated-rt-for-poor-prognosis-gbm-100618970","NCT07338539","BIO-SHORT: Hypofractionated RT for Poor-Prognosis GBM","BIOlogically-guided Short-course HypOfractionatedRadiation Therapy in Poor-prognosis GBM (BIO-SHORT): A Prospective Phase 2 Randomised Control Trial","BIO-SHORT","Inclusion Criteria:\n\n* Patients with biopsy proven IDH- wild type GBM or imaging defined GBM\n* Neurological Predictor Scale (NPS) = 2-3\n* Unfit for surgery and referred for direct RT\n* Age \\>\u002F= 50 years\n\nExclusion Criteria:\n\n* IDH mutant glioma\n* Histone altered glioma\n* Multifocal disease or Gliomatosis like appearance which necessitates whole brain RT\n* Disseminated disease in brain or spine\n* NPS = 0-1 or = 4\n* Karnofsky Performance Status score less than 50(Patient requires considerable assistance and frequent medical care)\n* Prior administration of any systemic therapy directed against glioma (eg.Temozolomide, CCNU, Bevacizumab)","50 Years",{"count":188,"type":22},108,[190],"NA","High grade gliomas, particularly glioblastoma, are among the most aggressive brain tumors and are associated with poor outcomes despite standard treatment. Many patients, especially older adults or those with poor general health, are not suitable for surgery and have a life expectancy of less than 12 months. Current standard includes a shortened course of radiotherapy (over 3 weeks) combined with chemotherapy using temozolomide (TMZ), which offers limited survival benefits. This study aims to explore whether delivering radiotherapy in a shorter duration (1 or 2 weeks) at a higher dose, guided by advanced imaging with a PET scan, can improve survival in this group of patients. PET scans help identify the most active parts of the tumor, which aids in targeting of these areas more precisely, potentially improving outcomes while reducing harm to healthy brain tissue. This study will randomly assign 116 eligible patients into two groups:\n\n* One group will receive the current standard of care (3-week radiotherapy + TMZ).\n* The other group will receive PET-guided radiotherapy over a shorter duration (either 5 or 10 sessions) at a higher dose, alongside TMZ.\n\nThe primary goal is to compare overall survival at one year between the two groups. The study will also assess how the disease progresses, side effects of treatment, and the impact on patients' quality of life. The study will be conducted over a total period of 6 years, including 4 years for patient enrolment and 2 years of follow-up. Participation in the study is entirely voluntary, and all patients will undergo an informed consent process. The study has been designed to follow all applicable ethical and regulatory guidelines. The results may help establish a more effective and convenient treatment option for patients with aggressive brain tumors and poor prognosis.",[193],"Glioma","2026-05-13",{"date":196,"type":36},"2026-05-18",{"date":198,"type":36},"2025-11-06",{"date":200,"type":22},"2031-10-27",{"name":42,"class":43},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":44},"100611150","self-administered-remote-neurological-examination-using-mobile-application-in-patients-with-brain-tumors-100611150","NCT07236840","Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors","NEMO","Inclusion Criteria:\n\n1. Diagnosis of brain tumors (histopathology\u002F radiology).\n2. Age \\> 5 years\n3. Patient or caregiver have access to an android smart phone and is able to install the mobile application.\n4. Expected survival more than 6 months during study accrual.\n5. Signing patient consent or parent consent\u002F child assent form (as appropriate).\n\nExclusion Criteria:\n\n1. Patient or caregiver is not reliable to follow instructions or use the mobile application.\n2. Patient with severe cognitive or psychiatric issues causing difficulty in using the app or follow instructions.\n3. Karnofsky Performance Status (KPS) or Lansky Performance Status LPS) \\\u003C50.\n4. Terminal illness with expected life expectancy (\\\u003C6 months).","5 Years",{"count":211,"type":22},600,"OBSERVATIONAL","The goal of this observational study is to evaluate the feasibility and accuracy of a self-administered remote neurological examination using the \"Iskhaa\" mobile application in patients with brain tumors aged above 5 years who are able to follow app-based instructions.\n\nThe main questions it aims to answer are:\n\n1. Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks.\n2. Development and validation of the AI model to detect functional changes and predict subsequent neurological deterioration.\n\nParticipants will:\n\n1. Use the Iskhaa mobile application to perform guided self-neurological examinations following pre-recorded video instructions.\n2. Complete EORTC QLQ-C30 and BN20 questionnaires for quality of life assessment.\n3. Record and upload videos (e.g., speech, walking, limb movements) using their mobile camera for analysis.\n4. In Phase 1 (onsite), 100 participants will use the app under supervision to ensure usability and accuracy.\n5. In Phase 2 (offsite), 500 participants will use the app independently at home for monthly self-assessments, with reminders and follow-up support.\n6. Continue routine clinic visits every 3-6 months and imaging every 6-12 months as per standard clinical care.\n\nThe study will compare app-recorded data with physician assessments to determine agreement and validity of remote neurological monitoring using artificial intelligence analysis.",[215,216,193,217],"CNS Tumor","Artificial Intelligence (AI)","Digital Health",[219,220,221],"neurological examination","mobile application","brain tumors","2026-02-21",{"date":224,"type":36},"2026-02-24",{"date":226,"type":36},"2026-02-20",{"date":228,"type":22},"2027-11-05",{"name":42,"class":43},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":104},"100550106","phase-3-short-versus-long-term-levetiracetam-in-brain-tumors-100550106","NCT06442748","Short Versus Long-term Levetiracetam in Brain Tumors","Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)","LIBRA","Inclusion Criteria: • Age ≥ 18years\n\n* History of seizure\n* Histological diagnosis of primary brain tumor\n* Supratentorial location of primary tumor\n* Controlled on levetiracetam monotherapy for 6 months\n* Index surgery within 1 year\n* Karnofsky Performance Scale (KPS) ≥ 50\n\nExclusion Criteria:\n\n* KPS \\\u003C 50\n* No history of seizure\n* Unclear history of seizure episodes in the past\n* Use of antiepileptics other than levetiracetam in the previous 6 months\n* No histological diagnosis\n* Progressive disease\n* Brain metastasis\n* Altered mental status with deficits in understanding or inability to consent to the study",{"count":239,"type":22},604,[241],"PHASE3","Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes.",[244,245,246,247],"Seizures","Brain Tumors","Antiepileptics","Levetiracetam","2026-02-11",{"date":250,"type":36},"2026-02-13",{"date":252,"type":36},"2024-07-04",{"date":254,"type":22},"2031-06-01",{"name":42,"class":43},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":44},"100623361","phase-ii-trial-of-immunonutrition-in-hepatectomy-100623361","NCT07395635","Phase II Trial of Immunonutrition in Hepatectomy","Impact of Immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors: A Randomized Controlled Phase II Trial","Inclusion Criteria:\n\n1. Patients with liver tumors planned for major hepatectomies (defined as resection of \\>\u002F= 3 liver segments)\n2. Age above 18 years\n3. ASA class I-III\n\nExclusion Criteria:\n\n1. Preoperative severe renal failure (estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n2. History of hypersensitivity to arginine, omega-3 fatty acids, or nucleotide 3. Inability to take oral nutrition\n\n4\\. Pregnancy 5. Mental condition rendering the subject unable to understand the nature, endpoints and consequences of the trial","90 Years",{"count":265,"type":22},100,[190],"A randomised open labelled study to evalaute the impact of immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors",[269,270],"Hepatocellular Carcinoma","ASA I-III Patients",[272,273],"Immunonutrition","Hepatectomy","2026-02-06",{"date":276,"type":36},"2026-02-09",{"date":278,"type":36},"2025-10-03",{"date":280,"type":22},"2028-01-31",{"name":42,"class":43},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":290,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":44},"100618969","intensity-modulated-proton-therapy-in-pediatric-brain-tumors-import-100618969","NCT07338526","Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)","Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial","IMPORT","Inclusion Criteria:\n\n* Age at irradiation: 6 to 16 years\n* Karnofsky\u002F Lansky Play Performance Status ≥ 60\n* Diagnosis (histopathological\u002F radiological) of primary brain tumor with an expected survival of \\>5 years (e.g., circumscribed gliomas, low grade gliomas, low-grade glial\u002F glioneuronal tumors, meningioma, pituitary tumors, schwannoma, craniopharyngioma, ependymoma)\n* Planned for focal cranial radiotherapy\n* Informed consent taken\n\nExclusion Criteria:\n\n* Re-irradiation\n* Palliative radiotherapy\n* Multifocal or multicentric disease\n* Planned for whole brain irradiation or craniospinal irradiation\n* Planned for hypo-fractionated or stereotactic radiotherapy","6 Years","16 Years",{"count":293,"type":22},94,[190],"Children diagnosed with benign or low-grade brain tumors often require radiation therapy to control their disease. While radiation can be effective, traditional techniques using X-rays (photon-based radiotherapy) expose healthy brain tissue to radiation, potentially leading to long-term side effects like memory loss, learning difficulties, hormone imbalances, hearing problems, and a higher risk of secondary cancers. This study, called the IMPORT Trial, aims to compare two types of radiation therapy-Intensity-Modulated Proton Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT)-to determine which is safer and more effective for children. IMPT, a newer technique, uses protons instead of X-rays to deliver radiation, reducing exposure to healthy brain tissue. Researchers believe this could help minimize long-term damage while maintaining effective tumor control.\n\nWhat is the goal of the study?\n\nThe primary goal is to see if IMPT leads to better survival with fewer side effects compared to IMRT. The study will track how well children function over five years, looking at:\n\n* Cognitive abilities (memory, attention, learning)\n* Hormonal balance (pituitary gland function)\n* Hearing ability\n* Overall survival without significant decline in quality of life\n\nHow will the study work?\n\n* Who can join? Children aged 6 to 16 years diagnosed with certain types of benign or low-grade brain tumors.\n* How are patients treated? Patients will be randomly assigned to receive either IMRT or IMPT.\n* What is analysed? Doctors will track survival, tumor control, cognitive function, endocrine health, and quality of life over time.\n* How long will it take? The study will last 10 years (5 years to enroll patients, 5 years to follow up).\n\nProton therapy is more expensive and not widely available, so strong scientific evidence is needed to justify its use in routine treatment. If IMPT significantly improves quality of life and survival, it could become the preferred treatment, shaping future policies and making proton therapy more accessible for children who need it.",[297],"Brain Tumor, Pediatric",[299,300],"Brain tumor, Benign","Brain tumor, Pediatric","2026-01-28",{"date":303,"type":36},"2026-01-30",{"date":305,"type":36},"2025-08-07",{"date":307,"type":22},"2035-07-07",{"name":42,"class":43},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":317,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":318,"conditions":319,"keywords":322,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":44},"100618917","prospective-evaluation-of-68ga-fapi-pet-in-biliary-cancers-100618917","NCT07337850","Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers","FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study","FAPi-2","Inclusion Criteria:\n\n* Suspected biliary tract cancers- iHCC and GBC\n* Male and females ≥ 18 years;\n* Upfront advanced (suspected T3 ,T4, N1, vascular involvement)\n* iGBC (residual, N1)\n* Suspected post-treatment recurrence (biochemical or radiological)\n\nExclusion Criteria:\n\n* Informed consent withdrawal\n* Concurrent Malignancy",{"count":21,"type":22},"The goal of this prospective observational study is to evaluate whether Gallium-68 Fibroblast Activation Protein Inhibitor (FAPI) PET\u002FCT can improve detection, staging, and recurrence assessment in adult patients (≥18 years) with suspected or confirmed biliary tract cancers, including gallbladder cancer, cholangiocarcinoma, and post-treatment suspected recurrence.\n\nThe main question(s) this study aims to answer are:\n\nCan FAPI PET\u002FCT provide greater sensitivity, specificity and diagnostic accuracy for primary tumors, nodal disease, and metastatic lesions compared to standard FDG PET\u002FCT?\n\nDoes FAPI PET\u002FCT offer additional diagnostic yield that may affect clinical decision-making and staging, potentially reducing need for invasive staging procedures?\n\nResearchers will compare FAPI PET\u002FCT with FDG PET\u002FCT to see if FAPI improves detection of metastatic or recurrent disease, especially peritoneal or liver metastasis and lymph node involvement.\n\nParticipants will:\n\nProvide written informed consent.\n\nUndergo FAPI PET\u002FCT imaging (baseline and\u002For at suspected biochemical or radiologic recurrence).\n\nHave quantitative imaging parameters evaluated (SUVmax, tumor-to-liver ratios, metabolic volume).\n\nMay undergo comparison with FDG PET\u002FCT and\u002For follow-up imaging or histopathology as gold standard.",[320,321],"Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma (Icc)",[323,324,325,326,327,328],"FAPI PET\u002FCT","Gallium-68 FAPI","Biliary Tract Cancer","Gallbladder Cancer","Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma (iHCC)","2026-01-01",{"date":331,"type":36},"2026-01-13",{"date":333,"type":36},"2024-09-25",{"date":335,"type":22},"2026-03",{"name":42,"class":43},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":354,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":44},"100579989","proton-versus-photon-radiotherapy-in-adults-with-primary-brain-tumors-100579989","NCT06831461","Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors","Proton Versus Photon Radiotherapy In Adults With Primary Brain Tumors Evaluating Functional Survival: A Phase 3 Randomized Controlled Trial (PRIDE)","PRIDE","Inclusion Criteria:\n\n* Primary brain tumors\n* Age at irradiation: 18 to 70 years\n* Karnofsky Performance Status ≥ 60\n* Diagnosis (histopathological\u002F radiological) of primary brain tumor with an expected survival of \\>5 years (e.g., grade 2-3 diffuse glioma, low-grade glial\u002F glioneuronal tumors, ependymoma, meningioma, pituitary tumors, schwannoma, craniopharyngioma, etc.)\n* Planned for focal cranial radiotherapy\n* Informed consent taken\n\nExclusion Criteria:\n\n* Re-irradiation\n* Palliative radiotherapy\n* Multifocal or multicentric disease\n* Planned for whole brain irradiation or craniospinal irradiation\n* Planned for hypo-fractionated or stereotactic radiotherapy",{"count":346,"type":22},156,[190],"This study will be done in adults with brain tumors having good prognosis requiring treatment with radiotherapy. The current practice for brain radiotherapy involves treatment using X rays (photon radiotherapy). Proton beam therapy is a more advanced form of delivering radiation, which allows the reduction of the dose of radiation to the parts of the brain surrounding the tumor. After treatment with photon radiotherapy, certain late effects of radiation, like memory decline, hormonal deficits, hearing loss, and worsening of neurological function, can occur in some patients. From the evaluation of dose profiling, proton beam therapy has the potential to reduce the possibility of side effects by reducing the dose to critical organs. However, there is no clinical data to demonstrate whether the theoretical dose reduction translates to a clinically meaningful benefit. In the proposed study, 156 patients will be randomly allocated to either proton or photon radiotherapy in 1: 1 ratio. The primary objective of the study is to explore whether proton therapy improves functional survival, which is life expectancy without recurrence, death, or complications from radiotherapy.",[350,28,351,352,353],"Primary Brain Tumors","Meningioma","Pituitary Adenoma","Low Grade CNS Tumors",[355,356,245,357,358],"Proton Beam Therapy","Photon Radiotherapy","Neurocognition","Survival","2025-09-15",{"date":361,"type":36},"2025-09-16",{"date":363,"type":36},"2025-07-01",{"date":365,"type":22},"2032-12-31",{"name":42,"class":43},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":44},"100520592","phase-2-effect-of-rifaximin-on-gut-bacterial-flora-post-stem-cell-transplant-in-patients-with-acute-leukemia-100520592","NCT06058572","Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia","Randomized Trial to Study the Effect of Rifaximin on Gut Microbiome Diversity Post Allogeneic Stem Cell Transplant in Acute Leukemia.","Inclusion Criteria:\n\n* Adults with acute leukemia undergoing allogeneic stem cell transplant.\n* ECOG performance status 0, 1 or 2.\n* Adequate Liver function\n\nExclusion Criteria:\n\n* Known hypersensitivity to rifaximin or other rifampicin antimicrobial agents\n* Current or past history of inflammatory bowel disease\n* History of major bowel resection or presence of colostomy.\n* Ongoing Verapamil, ketoconazole or itraconazole.",{"count":375,"type":22},166,[25],"* Goal: This study is a randomized phase II interventional study. The purpose of this study is to see if addition of oral rifaximin tablets during allogeneic stem cell transplant can improve the quality of gut microbiome and reduce chances of death, infections and graft versus host disease (GVHD) post-transplant.\n* The study objectives are as follows:\n* Primary Objective: To determine the impact of rifaximin on gut microbial diversity and compare it with controls.\n* Secondary Objectives: a. To determine non-relapse mortality at 1-year post transplant in patients who receive peri-transplant transplant rifaximin and compare it with controls.\n* b. To compare the incidence of severe GVHD in patients who receive peri-transplant rifaximin with the controls.\n* c. To determine impact of gut decontamination with rifaximin on incidence of MDR sepsis and usage of higher antibiotics (e.g. Carbapenems, colistin, tigecycline, ceftazidime avibactum and ceftriaxone-sulbactam EDTA) in first 6 months post BMT.\n* d. To determine the impact of rifaximin induced gut manipulation on immune reconstitution, T cell repertoire post-transplant and cytokine profile.\n* Exploratory objective: To use single cell transcriptomics (SCT) to identify immune cell profile in gut biopsies post allogeneic stem cell transplant whenever biopsy is done, to correlate the impact of microbiome on gut immunity.\n* Intervention: Tab Rifaximin 200 mg will be given orally twice daily from day -8 to day +60 of allogeneic stem cell transplant in acute leukemia patients. This will be in addition to standard of care post-transplant treatment.\n* Comparator Agent: Standard of care treatment including standard anti GVHD measures, antibiotic support and transfusions as needed.",[69],[380,381],"Rifaximin","Gut Microbiome","2025-07-30",{"date":384,"type":36},"2025-07-31",{"date":386,"type":36},"2024-08-02",{"date":388,"type":22},"2027-08-02",{"name":42,"class":43},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100597728","phase-3-trastuzumab-plus-chemotherapy-vs-chemotherapy-alone-in-first-line-her2-positive-advanced-biliary-tract-cancer-patients-100597728","NCT07062263","Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients","Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients - a Randomized Non-blinded Two-arm Phase III Prospective Clinical Trial (TAB-2 Study).","TAB-2","Inclusion Criteria:\n\nHistologically confirmed adenocarcinoma of the biliary tract, with the following specifications -\n\n1. Biliary tract cancers include gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma.\n2. HER2-positive by IHC or FISH\n3. Age \\>=18 years.\n4. ECOG performance status 0 - 2.\n5. Unresectable or metastatic cancer.\n6. Patient does not have any contraindications to receive chemotherapy or trastuzumab.\n7. Adequate hematological, hepatic, and renal function parameters- Hematological- Hb\\> 80 g\u002FL, ANC ≥ 1.5 x 109\u002FL, platelets ≥ 100 x 109\u002FL. Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST\u002FALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g\u002FL.\n\n   Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \\>= 30 mL\u002Fmin.\n8. Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) \\>=50% or above the lower limit of normal. ECG with no clinically relevant abnormalities.\n9. Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.\n10. Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.\n11. Subjects who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment. Patients who have received radiation therapy and surgery will also be eligible provided the interventions have been completed 3 and 2 weeks, respectively, before enrolment in the study.\n12. Negative serum pregnancy test (if applicable) and willing for adequate contraception.\n13. At least one measurable disease according to RECIST criteria.\n14. Life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Distal cholangiocarcinoma\n2. Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab- paclitaxel, or trastuzumab.\n3. Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III-IV.\n4. Clinically significant valvular defect.\n5. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.\n6. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n7. Baseline neuropathy \\> NCI Grade I.\n8. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.\n9. Received prior chemotherapy within 1 year.\n10. Any active ILD\u002F history of lung illness requiring bronchodilator drugs.\n11. Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.","99 Years",{"count":400,"type":22},220,[241],"This is a randomized, open-label, two-arm, Phase III clinical trial evaluating the efficacy and safety of trastuzumab plus chemotherapy versus chemotherapy alone as first-line treatment in patients with HER2-positive advanced or metastatic biliary tract cancers (BTC). HER2-positive BTCs represent a molecular subset of these rare cancers, associated with poor prognosis and limited treatment options.\n\nEligible patients with histologically confirmed HER2-positive (IHC 3+ or IHC 2+ with FISH amplification) unresectable or metastatic biliary tract adenocarcinoma-including gallbladder cancer, intrahepatic, and perihilar cholangiocarcinoma-will be randomized in a 1:1 ratio. Participants in the intervention arm (Arm A) will receive either gemcitabine and cisplatin with or without nab-paclitaxel plus trastuzumab, while those in the control arm (Arm B) will receive chemotherapy alone (gemcitabine + cisplatin with or without nab-paclitaxel). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.\n\nThe primary endpoint is 6-month progression-free survival (PFS). Secondary endpoints include overall survival (OS), response rate (RR), quality of life (QOL), and adverse event (AE) profiles. The study aims to enroll 196 patients across a single center in India over a period of 5 years, with an additional 6-month follow-up. This trial builds on earlier Phase II findings suggesting improved outcomes with trastuzumab in HER2-positive BTC and aims to provide the first randomized evidence for the benefit of HER2-targeted therapy in this setting.",[325,404,405,406,407],"HER2-positive Cancer","Advanced Cancer","Unresectable Biliary Tract Carcinoma","Metastatic Biliary Tract Carcinoma","2025-07-02",{"date":410,"type":36},"2025-07-14",{"date":412,"type":36},"2023-07-21",{"date":414,"type":22},"2029-07-31",{"name":42,"class":43},6,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":44},"100594609","phase-2-use-of-a-new-medicine-daratumumab-to-treat-left-over-cancer-in-a-blood-cancer-called-t-acute-lymphoblastic-leukemia-100594609","NCT07021677","Use of a New Medicine \"Daratumumab\" to Treat Left-over Cancer in a Blood Cancer Called \"T Acute Lymphoblastic Leukemia\"","Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study","DARA_T_ALL","Inclusion Criteria:\n\n1. Adults ≥18 - ≤65 years of age\n2. Baseline diagnosis of T-ALL, including ETP-ALL\n3. MRD positive (≥0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1\n4. CD38 positive\n5. Eastern cooperative oncology group (ECOG) performance status ≤2\n6. Acceptable liver functions, as specified below:\n\n   Total bilirubin \\\u003C2 times upper limit of normal (ULN); Aspartate transaminase (AST;SGOT), alanine transaminase (ALT;SGPT) \\\u003C3 ULN\n7. Subject ready to sign an informed consent form\n8. Patients with baseline CSF cytology positive, but who have cleared CSF by either modality (cytology or flow cytometry)\n\nExclusion Criteria:\n\n1. T-LBL (T-lymphoblastic lymphoma) without BM involvement\n2. Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement\n3. Patients with symptomatic obstructive airway disease, as per assessing clinician\n4. Presence of an active systemic infection, as per assessing clinician\n5. New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \\\u003C40%\n6. Human immunodeficiency virus (HIV) positive.\n7. Pregnant or breastfeeding female\n8. HBsAg positive or HBV-DNA positivity",{"count":426,"type":22},18,[25],"T-ALL (T-acute lymphoblastic leukemia) is an aggressive blood cancer, wherein patients who are MRD positive after two courses of induction chemotherapy have poor outcomes. This goal of this study is to determine if Daratumumab can make such T-ALL patients MRD negative.\n\nThe main questions this study aims to answer are -\n\n1. Whether MRD Positive T-ALL patients can become MRD negative after two doses of daratumumab?\n2. Whether MRD Positive T-ALL patients can become MRD negative after four doses of daratumumab?\n3. Whether addition of daratumumab can affect the risk of progression or death at 1-year?\n4. Whether daratumumab is safe to use?\n\nNewly diagnosed patients of T-ALL who are MRD positive after two courses of induction chemotherapy will be eligible to receive daratumumab. These patients will receive two doses of weekly intravenous daratumumab at standard dose (16mg\u002Fkg), and will undergo repeat evaluation of MRD from bone marrow one week after the second dose of daratumumab. Patients who become MRD negative will continue chemotherapy as per institutional policy. Those who remain MRD positive will be eligible to receive two additional doses, and will undergo another bone marrow MRD testing one week after the fourth dose. Irrespective of the results after the fourth dose, patients will be continued on chemotherapy as per institutional policy.",[430],"T Acute Lymphoblastic Leukemia",[432,433,434,435,436],"daratumumab","T-Acute lymphoblastic leukemia","minimal residual disease","MRD","Post induction MRD","2025-06-13",{"date":439,"type":36},"2025-06-15",{"date":441,"type":36},"2023-08-28",{"date":443,"type":22},"2026-08-28",{"name":42,"class":43},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":452,"minAge":18,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":461,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":104},"100505152","postoperative-hypofractionated-radiation-in-cervical-and-endometrial-tumours-phase-ii-study-100505152","NCT05857631","Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study","PARCERII","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with\u002Fwithout vaginal brachytherapy.\n\nExclusion Criteria:\n\n1. Patients with macroscopic residual disease (R+ resection) postoperatively\n2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)\n3. Patients treated with chemotherapy for any prior malignancy at any time\n4. Patients treated with pelvic radiation previously\n5. Patients with human immunodeficiency virus infection\n6. Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)","FEMALE","80 Years",{"count":455,"type":22},90,[190],"The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.",[459,460],"Cervical Cancer","Endometrial Cancer",[462,463,464,465],"Hypofractionated Radiation","Radiotherapy, Adjuvant","Radiotherapy, Intensity modulated","Late gastrointestinal and genitourinary toxicities","2025-04-10",{"date":468,"type":36},"2025-04-15",{"date":470,"type":36},"2023-05-29",{"date":472,"type":22},"2029-05-25",{"name":42,"class":43},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":17,"minAge":209,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":485,"conditions":486,"keywords":489,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":44},"100575992","systemic-biomarkers-to-predict-radiation-induced-neurocognitive-decline-100575992","NCT06779487","Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline","Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline in Pediatric and Young Adults With Primary Brain Tumors (BIO-RIN)","BIO-RIN","Inclusion Criteria:\n\n1. Age 5-39 years\n2. Histological diagnosis of primary brain tumor\n3. Decision for treatment with radical intent radiotherapy\n4. Signed assent and parental consent form for pediatric age group and signed consent form for adults.\n\nExclusion Criteria:\n\n1. Inability to undergo neurocognitive evaluation\n2. Palliative radiotherapy.\n3. Expected life expectancy \\\u003C 1 year","39 Years",{"count":484,"type":22},200,"Radiation constitutes an integral component in the management of primary brain tumors in pediatric and young adults like medulloblastoma, ependymoma, low-grade glioma, pituitary tumors, etc. A decline in neurocognitive outcomes is a multifactorial effect occurring from the primary disease as well as associated with treatments, including radiation. Since many of these tumors are highly curable, it is crucial to reduce long-term side effects, including memory loss, to improve the quality of life in these patients, leading to better rehabilitation. Radiation-induced neurocognitive deterioration is postulated to occur from multiple factors like neuroinflammation, vascular damage, and depletion of neural stem cells. The proposed study will prospectively evaluate 200 pediatric and young adults with brain tumors treated with radiotherapy. Biological samples (peripheral blood and cerebrospinal fluid) will be procured during routine investigations (an additional amount will be collected for study purposes without the need for additional investigations). Serial blood markers (whenever available pre-operative and before, during, and after completion of radiation) of neuroinflammation and neural markers will be tested in patients undergoing radiation as part of their standard treatment, and correlate with the neurocognitive outcomes measured by age-appropriate Wechsler intelligence scales. Also, the impact of clinical (e.g. age) and radiotherapy parameters like volume, dose of radiation, and technique (photon versus proton therapy) on acute (during radiotherapy) and late systemic inflammatory markers will be analyzed. The study will even provide the opportunity to know the influence of radiation on systemic neuroinflammatory markers in the human population, providing better biological insights into the neurocognitive decline. If proven successful, these biomarkers can be used in routine clinical practice for early intervention to improve neurocognitive function in patients receiving radiation (even for other histology or other patients receiving radiation like brain metastasis).",[245,487,193,488],"Medulloblastoma","Ependymoma",[490,491,355,492,493],"Brain Tumor","Radiotherapy","Neuro-cognition","Bio-markers","2025-04-08",{"date":496,"type":36},"2025-04-11",{"date":498,"type":36},"2025-02-11",{"date":500,"type":22},"2032-02",{"name":42,"class":43},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":44},"100545409","tracing-brain-tumors-through-deep-time-100545409","NCT06381531","Tracing Brain Tumors Through Deep Time","TRACE","Inclusion Criteria:\n\n• All patients diagnosed with primary brain tumors with available pre\u002F post-operative or pre-radiation brain images with computed tomography (CT) or magnetic resonance imaging (MRI)\n\nExclusion Criteria:\n\n* CT\u002F MRI is not available before cranial radiotherapy\n* Artifacts causing distortion of skull (bony) anatomy",{"count":510,"type":22},10000,"Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology.",[490,513],"Oncology",[515,516,517],"CNS tumor","Brain tumor","Evolution",{"date":496,"type":36},{"date":520,"type":36},"2025-01-10",{"date":522,"type":22},"2027-06-10",{"name":42,"class":43},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":209,"maxAge":482,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":44},"100537223","phase-3-evaluation-of-memantine-in-the-preservation-of-memory-and-neurocognition-following-csi-100537223","NCT06275035","Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI","Memantine to Preserve Memory and Neurocognition Following Craniospinal Irradiation- A Randomised Controlled Trial (MEMENTO)","MEMENTO","Inclusion Criteria:\n\n* Age at irradiation: 5 to 39 years\n* Planned for CSI (with or without boost dose) with or without systemic chemotherapy\n* Informed consent or assent taken\n* Karnofsky Performance Status \u002F Lansky Performance Status ≥ 60\n\nExclusion Criteria:\n\n* Re-irradiation\n* Prior exposure to memantine\n* Inability to undergo Wechsler test",{"count":533,"type":22},101,[241],"The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy.",[537],"Neurocognitive Dysfunction",{"date":539,"type":36},"2025-04-09",{"date":541,"type":36},"2024-02-22",{"date":543,"type":22},"2031-01",{"name":42,"class":43},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":558,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":44},"100532574","phase-2-radiation-therapy-in-unresectable-gall-bladder-cancer-100532574","NCT06214572","Radiation Therapy in Unresectable Gall Bladder Cancer","Systemic Therapy With or Without Radiation Therapy in Unresectable Nonmetastatic Gall Bladder Carcinoma: Open Label, Parallel Arm, Phase 2\u002F3 Integrated Randomized Clinical Trial","RUGB","Inclusion Criteria:\n\n* Histologically proven (biopsy\u002Fcytology) adenocarcinoma of gall bladder. Gall bladder neck primaries with hilar block mimicking hilar cholangiocarcinoma will also be included.\n* Non metastatic at presentation as determined using cross sectional imaging and diagnostic laparoscopy if done as a part of standard work up recommended in the joint clinic.\n* Locally advanced disease with one or more of the following\n* Extensive liver infiltration not amenable for surgery but feasible for safe radiation delivery (Liver minus gross tumor volume at least 700cc)\n* Vascular involvement: encasement (\\>180-degree angle) of one of the vessels: Hepatic artery, main portal vein, right or left portal vein\n* Obstructive jaundice with hilar involvement (type 2 non communicating block and higher blocks as per Bismuth-Corlette classification)\n* Stable disease or partial response (RECIST 1.1) after initial 3 months of Gemcitabine based chemotherapy\n* More than 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 fit for chemotherapy\n* Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy\n* Hematological- Hb\\> 80 g\u002FL, ANC ≥ 1.5 x 109\u002FL, platelets ≥ 100 x 109\u002FL.\n* Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST\u002FALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g\u002FL\n* Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \\>= 50 mL\u002Fmin\n\nExclusion Criteria:\n\n* Patients with distant metastasis (including nonregional lymph nodes metastasis) will be excluded.\n* Prior abdominal therapeutic radiation\n* Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix\n* Pregnancy\u002FLactating women",{"count":554,"type":22},249,[25,241],"The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and\u002For immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are:\n\n* Whether adding radiation therapy to systemic therapy improves overall survival?\n* What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.",[320],[559,320,560,561],"Biliary tract cancer","Radiation therapy","Unresectable",{"date":496,"type":36},{"date":564,"type":36},"2024-03-07",{"date":566,"type":22},"2029-07-21",{"name":42,"class":43},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":576,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":44},"100518888","artificial-intelligence-in-cns-radiation-oncology-100518888","NCT06036394","Artificial Intelligence in CNS Radiation Oncology","Artificial Intelligence in Radiation Oncology for CNS Tumors","AI-RAD","Inclusion Criteria:\n\n• Patients with CNS tumors treated with radiation in TMC between January 2010 and December 2022.\n\nExclusion Criteria:\n\n* RT treatment outside TMC.\n* Radiation planning not done in the treatment planning system (treated using clinical marking\u002F conventional simulator).","1 Year",{"count":578,"type":22},6000,"Radiotherapy involves the use of high-energy X-rays, which can be used to stop the growth of tumor cells. Radiotherapy constitutes an essential avenue in the treatment of brain tumors. The modern techniques of radiotherapy involve radiation planning techniques guided by computer algorithms aimed to deliver high doses of radiation to the areas of brain with tumors and limit the doses to surrounding normal structures. Artificial intelligence uses advanced analytical processes aided by computational analysis, which can be undertaken on the medical images, and radiation planning process. We plan to use artificial intelligence techniques to automatically delineate areas of the brain with tumor and other normal structures as identified from images. Also, we will use artificial intelligence on the radiation dose images and other images done for radiation treatment to classify tumors with good or bad prognoses, identify patients developing radiation complications, and detect responses after treatment.",[215],[516,193,582,31,583],"Radiation Oncology","Machine learning",{"date":539,"type":36},{"date":586,"type":36},"2023-09-13",{"date":588,"type":22},"2028-09",{"name":42,"class":43},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":576,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":44},"100518887","spatial-and-temporal-characterization-of-gliomas-using-radiomic-analysis-100518887","NCT06036381","Spatial and Temporal Characterization of Gliomas Using Radiomic Analysis","GLIO-RAD","Inclusion Criteria:\n\n* Patients with glioma or glioma-mimicking pathology with imaging available in TMC between January 2010 and December 2022.\n\nExclusion Criteria:\n\n* Imaging done outside TMC.\n* Motion artifacts or other artifacts causing image degradation.\n* Size of tumor or region of interest \\\u003C 1 cm in the largest dimension",{"count":598,"type":22},1000,"Glioma are type of primary brain tumors arising within the substance of brain. Different type of gliomas are seen which are classified depending upon pathological examination and advanced molecular techniques, which help to determine the aggressiveness of the tumor and outcomes. Artificial intelligence uses advanced analytical process aided by computer which can be undertaken on the medical images. We plan to use artificial intelligence techniques to identify the abnormal areas within the brain representing tumor from the radiological images. Also, similar approach will be undertaken to classify gliomas with good or bad prognosis, to differentiate glioma from other type of brain tumors, and to detect response after treatment.",[193],[193,602,31,583],"Radiomics",{"date":539,"type":36},{"date":605,"type":36},"2024-02-15",{"date":607,"type":22},"2026-12",{"name":42,"class":43},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":44},"100517354","phase-2-a-study-of-chlorophyllin-for-the-management-of-brain-radio-necrosis-in-patients-with-diffuse-glioma-100517354","NCT06016452","A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma","A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma","CHROME","Inclusion Criteria:\n\n* Histological diagnosis of diffuse glioma.\n* Radionecrosis on imaging with new neurological symptoms\u002F worsening of prior deficits (Stratum A) or\n* without new symptoms (Stratum B).\n* Karnofsky Performance Scale (KPS) ≥ 50.\n\nExclusion Criteria:\n\n* No tissue diagnosis.\n* KPS\\\u003C 50.\n* Disease progression\n* Contraindications to corticosteroids.\n* Altered mental status with deficits in understanding or inability to consent to the study.\n* Brainstem glioma\n* Indeterminate for radionecrosis vs disease progression\n* Prior treatment with bevacizumab (either for disease progression or radionecrosis)",{"count":618,"type":22},118,[25],"Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN).\n\nAt the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients.\n\nThis is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis.\n\nChlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent.\n\nThis is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years.\n\nThe study is funded by Bhabha Atomic Research Centre (BARC).",[28,622,623,624],"Radionecrosis of Brain","High Grade Glioma","Glioblastoma Multiforme",{"date":496,"type":36},{"date":627,"type":36},"2023-11-13",{"date":629,"type":22},"2025-11",{"name":42,"class":43},{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":637,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":17,"minAge":639,"maxAge":291,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":44},"100398961","focal-radiotherapy-plus-low-dose-craniospinal-irradiation-followed-by-adjuvant-chemotherapy-in-wnt-medulloblastoma-100398961","NCT04474964","Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Medulloblastoma.","Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Subgroup Medulloblastoma.","FOR-WNT2","Inclusion Criteria:\n\n* Age more than 3 years and less than 16 years.\n* Newly diagnosed WNT pathway medulloblastoma.\n* Post-surgery residual disease less than 1.5 cm2 on post-operative MRI brain.\n* No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF) assessed by MRI of the brain\u002Fspine and lumbar puncture for CSF cytology.\n* Fit for initiation of adjuvant treatment within 6-weeks of surgery\n\nExclusion Criteria:\n\n* Age Less than 3 and more than 16 years.\n* Molecular subgroup other than WNT pathway.\n* Post-surgery residual disease more than 1.5cm2 on post-operative imaging.\n* Evidence of any metastatic disease in the brain, spine or CSF.\n* Previous history of radiotherapy or chemotherapy prior to study enrollment.\n* Not fit for initiation of adjuvant treatment within 6 weeks of surgery.\n* Not willing for consent\u002Fassent.","3 Years",{"count":641,"type":22},30,[190],"This clinical study is going to be done on a type of brain tumor in children called Medulloblastoma. The WNT pathway type of medulloblastoma is considered to be low risk and have the best outcomes in terms of survival. With the current standard of care for this type of medulloblastoma it is believed by the investigators that we are over treating the disease and increasing the long term side effects of these children. Several groups in the world are testing de-intensification of treatment in this favourable subset of children who experience long term late side effects of therapy. By reducing the dose to the craniospinal axis and keeping the total tumor bed dose the same in this study the investigators are expecting to reduce some of the late side effects of craniospinal irradiation without compromising disease control and survival.",[645],"Medulloblastoma, WNT-activated",[647,648,649,650],"WNT medulloblastoma","low dose craniospinal irradiation","overall survival","long term toxicities",{"date":539,"type":36},{"date":653,"type":36},"2020-08-13",{"date":655,"type":22},"2030-07",{"name":42,"class":43},""]