[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tata Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100578864","measuring-ultrasound-guided-skeletal-muscle-mass-of-lower-extremity-as-a-predictor-of-post-operative-length-of-stay-in-exploratory-gynae-oncology-surgeries-100578864",false,"NCT06816836","Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-Operative Length of Stay in Exploratory Gynae-oncology Surgeries","MUSLES","Inclusion Criteria:\n\n* All consecutive consenting patients above 50 years of age, having a Charlson Comorbidity Index score of 3 or more, undergoing open surgeries for GCs.\n\nExclusion Criteria:\n\nA. Refusal of consent B. Patients with psychiatric illnesses who are unable to follow instructions. C. Patients below the age of 50 years. D. Patients with known neuromuscular disorders. E. Patients in whom contrast-enhanced CT scan of the abdomen and pelvis is not done.\n\nF. Previous major surgery of limbs (Amputation, Hip surgeries\u002F long bone surgeries)","FEMALE","50 Years","99 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","Increased incidence of Gynae-oncological cancer is observed specifically in women above 50 years of age. Sarcopenia (a progressive and generalized loss of skeletal muscle mass, quality, and strength) is considered a reliable indicator of frailty, a poor prognostic factor in these patients. Various frailty scores and measurement of psoas muscle mass are time consuming, can't be done in patients unable to walk and altered mental status. The investigators wanted to evaluate if bedside ultrasound guided skeletal muscle measurement, as a measure of sarcopenia, can be used to predict post operative length of stay.",[25,26,27],"Gynecologic Cancer","Frailty","Sarcopenia",[25,29,26,27],"Post operative Stay","RECRUITING","2025-05-22",{"date":33,"type":34},"2025-05-29","ACTUAL",{"date":36,"type":34},"2025-04-01",{"date":38,"type":21},"2027-09-30",{"name":40,"class":41},"Tata Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100346245","one-week-versus-three-week-in-adjuvant-radiotherapy-in-breast-cancer-100346245","NCT03788213","One Week Versus Three Week in Adjuvant Radiotherapy in Breast Cancer","HYPOfractionated Radiation Therapy Comparing a Standard Radiotherapy Schedule (Over Three Weeks) With a Novel One Week Schedule in Adjuvant Breast Cancer: An Open Label Randomised Controlled Study (HYPORT- Adjuvant)","HYPORTAdjuvant","Inclusion Criteria:\n\n* Histologically or cytologically confirmed invasive breast cancers\n* Age \\> 18 years\n* ECOG performance status : 0 - 3\n* Underwent curative intent surgery for the breast cancer with complete microscopic resection either in the form of a mastectomy or breast conservation surgery\n* Adequate axillary clearance or a validated sentinel node biopsy procedure. For the purpose of this study, adequacy of the axillary clearance will be determined by a multidisciplinary tumor board and rationale for the decision documented in the case records. As a general guideline, at least 10 axillary lymph nodes need to be sampled for an axillary nodal dissection to be considered as adequate.\n* Absence of distant metastases. Patients who have high risk breast cancer as defined by a Nottingham Prognostic Index (NPI) of \\> 5.4 will be considered for metastatic workup in the form of a 18 FDG PET CT. Alternatively, a CT scan of the thorax and whole abdomen, and a bone scan is also allowed. Metastatic workup will also be recommended in patients with AJCC 8 T3\u002FT4 tumors at presentation, 4 or more nodes positive after surgery (pN2 or above). Patients with low or intermediate NPI will be considered for metastatic workup on a case by case basis. Metastatic workup will also be recommended for all patients undergoing neoadjuvant chemotherapy for locally advanced breast cancers.\n* Clear margins of resection for the breast primary as defined by absence tumor on ink in the specimen if a breast conservation has been performed or excision upto the deep fascia of the pectoralis major or skin.\n* Adjuvant radiotherapy is indicated. The following patients will be considered as candidates to receive adjuvant radiotherapy:\n* All patients after breast conservation surgery or after neoadjuvant chemotherapy\n* Patients after mastectomy if any of the below:\n\n  * T3 - T4 tumors\n  * more than 3 axillary lymph nodes\n  * T0-T2 tumor with 0 - 3 axillary lymph nodes with a Cambridge Score of 3 or more.\n* The SCF will be included in patients with axillary nodal involvement in pathology or in those patients who have undergone neoadjuvant chemotherapy. The internal mammary nodes will be included based on the institutional policy.\n\nExclusion Criteria:\n\n* Presence of any one of the following will exclude the patient from participation in the study:\n* Patients with pure ductal carcinomas in situ (in patients undergoing upfront surgery).\n* Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors\n* Patients with metaplastic breast cancers\n* Presence of pathologically proven residual supraclavicular nodal metastases or residual internal mammary lymphadenopathy at time of radiotherapy.\n* Prior radiotherapy to the ipsilateral breast\u002Fchest wall or the mediastinum. Patients with synchronous \u002F metachronous contralateral breast malignancies will be eligible for inclusion. Patients requiring bilateral breast radiotherapy are also eligible for inclusion.\n* Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety\n* Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.\n* Patients planned for concurrent chemotherapy during radiation therapy. Concurrent hormonal therapy or targeted therapy using anti-HER2 agents is allowed.","18 Years",{"count":53,"type":21},2100,"INTERVENTIONAL",[56],"NA","Background:Moderate three week hypofractionated adjuvant radiotherapy schedule is a standard care in breast cancers. A five day schedule has been demonstrated to be iso-toxic as a standard three week schedule. Recently studies have also demonstrated the safety and feasibility of simultaneous integrated boost in this setting. This randomized trial will investigate if a one-week course of hypofractionated breast radiotherapy is non-inferior to a three week course.\n\nAim: To determine if one-week schedule of adjuvant radiotherapy in breast cancer is non-inferior to a three week schedule.\n\nPrimary Objective: Locoregional Recurrence Rate (LRR) (Cumulative proportion of patients with locoregional recurrence) at 5 years\n\nSecondary Objective:\n\n1. Overall survival (OS) (Time from randomization to death)\n2. Invasive Disease-free survival (iDFS) (Time from randomization to any invasive disease recurrence, death due to any cause or second invasive malignancy)\n3. Late adverse events (AE)\n4. Quality of Life (QoL)\n\nHypothesis:\n\n1. 1 week schedule will be non-inferior to a three week schedule for Locoregional Recurrence Rate\n2. 1 week schedule will be non-inferior to a three week schedule for OS\n3. 1 week schedule will be not result in worse late adverse events as compared to 3 week schedule\n4. Proportion of patients decrease in quality of life will not differ between the two arms at 12 months\n\nDesign: Open-label, parallel group, two arm, randomised, phase III, non-inferiority trial.\n\nPopulation: Patients with breast cancer who need adjuvant radiotherapy after breast conservation or mastectomy.\n\nIntervention: Patients will be randomized to 15 days or 5 days of radiotherapy to the whole breast or chest wall or reconstructed breast. Nodal radiation will be delivered as indicated. A simultaneous integrated boost (SIB) will be delivered to patients who need a tumor bed boost after breast cancer. The following dose schedules will be tested:\n\nControl Group: 40 Gy in 15 fractions over 3 weeks (with SIB of 8 Gy)\\*\n\nTest Group: 26 Gy in 5 fractions over 1 week (with SIB of 6 Gy).\\*\n\n\\* Use of Sequential Boost is allowed in both arms if prespecified by the institution. If used dose is 12 Gy in 4 fractions in 1 week in both arms.\n\nOutcomes and measures:\n\n1. LRR : Cumulative proportion of patients with ipsilateral Locoregional Recurrence after treatment at 5 years .\n2. OS: Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years.\n3. iDFS: Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer.Cumulative proportion reported at 5 years.\n4. AE: Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria\n5. QoL: Proportion of patients with a worse summary score in the EORTC QLQ C30 at 12 months post-treatment as compared to the baseline score.",[59],"Breast Cancer Female",[61,62,63,64],"Hypo-fractionated Radiotherapy,","One week Radiotherapy","Simultaneous integrated boost","Breast Cancer","2024-10-21",{"date":67,"type":34},"2024-10-23",{"date":69,"type":34},"2019-03-26",{"date":71,"type":21},"2029-03-26",{"name":40,"class":41},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":51,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":54,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":42},"100557329","trial-comparing-avg-global-qual-of-lifescore-in-hypo-frac-rt-vs-conv-frac-in-hn-cancers-100557329","NCT06536699","Trial Comparing Avg. Global Qual of Lifescore in Hypo Frac. RT vs Conv. Frac. in H&N Cancers","A Randomised Non Inferiority Trial to Compare the Average Global Quality of Life Score Following Hypofractionated Radiotherapy Versus Conventional Fractionation in Head and Neck Cancers","HYPORT-HN","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. ECOG performance status 0 - 2.\n3. Patients diagnosed with invasive squamous cell cancer of the head and neck region which includes lip, oral cavity, nasopharynx, oropharynx, hypopharynx, supraglottis, glottis and subglottis.\n4. Patients who are being treated with curative intent treatment either with surgery followed by adjuvant radiotherapy with or without chemotherapy or definitive chemoradiation.\n5. Patients must have a histopathological proof of malignancy, such as biopsy or post operative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.\n6. Patients with non metastatic cancer, optimally staged with the following:\n\n   1. Contrast enhanced CT scan of the neck and thorax for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis\n   2. Magnetic Resonance Imaging of the neck and CT thorax for cancer of nasopharynx\n\nExclusion Criteria:\n\n1. Concurrent illness like severe cardiac, renal or hepatic dysfunction and, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety\n2. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.","ALL","80 Years",{"count":84,"type":21},600,[56],"Radiotherapy forms an integral part of Head and Neck cancer treatment in both definitive as well as adjuvant setting. This study explores the use of hypofractionated radiotherapy, delivering 55Gy in 20 fractions over 4 weeks in comparison to the conventional approach which involves 70 Gy over 6 weeks.\n\nHypofractionated radiotherapy would result in significant benefits in terms of shortening the overall treatment time, countering accelerated hypofraction effects that typically arise after the 4th week. The new approach is also anticipated to offer resource and financial advantages, involving less machine time per patient, and potentially leading to better patient compliance. Previous studies on hypofractionation in Head and Neck cancer have demonstrated good local control and acceptable toxicity levels compared to conventional methods.\n\nThe primary objective of this study is to compare the average global quality of life following hypofractionated radiotherapy versus conventional fractionation, with secondary objectives including a comparison of locoregional control at 2 years and assessment of acute and late toxicities.\n\nThe study will require 600 eligible patients randomly assigned to either the hypofractionated or conventional arm. For definitive chemoradiation, the control arm will receive 66Gy in 30 fractions over 6 weeks, while the experimental arm will receive 55Gy in 20 fractions over 4 weeks, along with Inj Cisplatin @ 100mg\u002Fm2 3 weekly for 2 cycles. In the adjuvant setting control arm will receive 60Gy in 30 fractions over 6 weeks and experimental arm will receive 52.5Gy in 20 fractions over 4 weeks along with Inj Cisplatin @ 100mg \u002Fm2 3 weekly for 2 cycles for both arms based on histopathological indications.\n\nPhysician reported and patient reported acute toxicities like mucositis, dermatitis and dysphagia, weight loss, requirement and duration of feeding tubes as well as patients reported outcomes in the form of EORTC QLQ C30, HN43 and XeQoLS will be recorded both during and after treatment at regular intervals for 2 years.\n\nThe study's duration is five years, aiming to determine whether the hypofractionated schedule is non-inferior to conventional radiotherapy in terms of safety and disease-related outcomes",[88],"Radiation Treatment",[90,91],"Hypofractionated radiotherapy","Head and Neck cancer","NOT_YET_RECRUITING","2024-08-02",{"date":95,"type":34},"2024-08-05",{"date":97,"type":21},"2024-08-07",{"date":99,"type":21},"2031-07-01",{"name":40,"class":41},""]