[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100641408","observe-a-pilot-study-of-omission-of-brain-metastasis-stereotactic-radiosurgery-following-resection-with-cns-active-systemic-therapy-100641408",false,"NCT07655583","OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy","Eligibility Criteria\n\n1. Age ≥ 18 years.\n2. ECOG performance status ≤ 2.\n3. Participants with a resected brain metastasis with gross total resection and pathologic confirmation of NSCLC or melanoma. Gross total resection must be confirmed based on a review of the operative report, pathology, and all post-operative images available at the time of enrollment.\n4. Brain metastasis resection occurred ≤ 5 weeks ago.\n5. Additional prior surgeries, including Laser Interstitial Thermal Therapy (LITT), to the same or nearby location are permitted, provided that residual disease or local recurrence is confirmed pathologically at the most recent resection.\n6. The resected lesion has never previously been targeted by radiotherapy.\n7. Evaluation by a brain metastasis multidisciplinary team (BM-MDT), consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon, and agreement that the intracranial cavity does not or will not require immediate post-operative radiation (i.e. it is judged to be safe to omit post-operative radiation). This BM-MDT evaluation can take place in clinic or during a multidisciplinary conference, either before or after the surgical resection. If the BM-MDT evaluation was before the surgical resection, there can be no new findings in the interim (e.g. during or after the surgical resection) that would change the BM-MDT's recommendation, as determined by one or more of the patient's treating physicians.\n8. Documentation by the patient's primary medical oncologist of a planned study systemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant (e.g. Exon 19 deletion; L858R) NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged\u002Ffusion positive NSCLC. As new agents are approved, other highly-CNS active tyrosine kinase inhibitors for participants with NSCLC may be included at the discretion of the principal investigator.\n9. For a participant with more than one recently resected brain metastasis that meets eligibility criteria #3-#7 above, it is permissible (but not mandated) for more than one surgical cavity to proceed without immediate post-operative radiation. All other intracranial disease must proceed with treatment according to standard-of-care practices at the time of enrollment. This may include treatment with SRS or observation if clinically appropriate.\n10. Regarding prior systemic therapy:\n\n    1. For participants with melanoma: no prior disease progression on any immune checkpoint inhibitor agent and ≥ 6 months between the last dose of any immune checkpoint inhibitor agent and initiation of the study systemic therapy regimen.\n    2. For participants with EGFR Mutant NSCLC: no prior disease progression on any EGFR-targeted tyrosine kinase inhibitor and ≥ 6 month between the last dose of any EGFR-targeted tyrosine kinase inhibitor and initiation of the study systemic therapy regimen.\n    3. For participants with ALK rearranged\u002Ffusion positive NSCLC: no prior disease progression on any ALK-targeted tyrosine kinase inhibitor and ≥ 6 month between the last dose of any ALK-targeted tyrosine kinase inhibitor and initiation of the study systemic therapy regimen.\n11. This study will allow non-English speaking subjects to be enrolled. Verbal Translation Preparative Sheet (VTPS) will be used if a translated consent form is not available in the subject's language. The consent form will be translated into the language of the subject after 2 or more occurrences. This will apply to any MD Anderson patient.\n\nExclusion Criteria\n\n1. History of known leptomeningeal involvement (radiographic or cytological).\n2. Subjects that have previously received or are currently planned for whole brain radiotherapy.\n3. Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy.\n4. Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.\n5. Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.\n6. Pregnancy or plans to become pregnant during the duration of the study.","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","OBSERVATIONAL","To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.",[23,24,25,26],"Brain Metastasis","Stereotactic Radiosurgery","Resection","Systemic Therapy","RECRUITING","2026-07-30",{"date":30,"type":31},"2026-08-03","ACTUAL",{"date":33,"type":31},"2026-05-27",{"date":35,"type":19},"2030-06-30",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100556665","treatment-of-anastomotic-leakage-after-colon-cancer-resection-100556665","NCT06528054","TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection","TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study","TENTACLE-Colon","Inclusion criteria:\n\n* Aged 18 years or older;\n* Surgical resection for primary colon cancer (cT1-4b, N0-2, M0-1) with formation of a primary colonic anastomosis and with or without diverting stoma;\n* Postoperative AL defined as: \"any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. This also includes suspected leaks with any degree of extraluminal air or fluid on CT, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis.\"\n* Regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (CRS) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (HIPEC), simultaneous ablations\u002Fresections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease\u002Fperitumoral abscess or fistula, and acute obstructions.\n\nExclusion criteria:\n\n* Surgical resection for benign colon disease;\n* Recurrent colon cancer resection;\n* Any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour);\n* Any clinical condition that does not fulfil the broad definition of AL as used in this study (e.g. only free air on CT that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)",{"count":49,"type":19},2000,"This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:\n\n1. To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.\n2. To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.",[52,53,25,54],"Treatment","Anastomotic Leakage","Colon Cancer","NOT_YET_RECRUITING","2024-07-29",{"date":58,"type":31},"2024-07-30",{"date":60,"type":19},"2024-10",{"date":62,"type":19},"2026-03",{"name":64,"class":38},"Radboud University Medical Center"]