[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100347536","phase-3-benefit-of-intensified-peri-operative-chemotherapy-within-high-risk-cinsarc-patients-with-resectable-soft-tissue-sarcomas-100347536",false,"NCT03805022","Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas","Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas","CIRSARC","Inclusion Criteria :\n\n1. Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,\n2. Grade 2 or 3 according to the FNCLCC grading system,\n3. Available archived tumour sample for research purpose,\n4. Non-metastatic and resectable disease,\n5. No prior treatment for the disease under study,\n6. Age ≥ 18 years,\n7. Life expectancy ≥ 3 months,\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,\n9. Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy,\n10. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year,\n11. Voluntarily signed and dated written informed consents prior to any study specific procedure,\n12. Patients with a social security in compliance with the French law.\n\nExclusion Criteria :\n\n1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,\n2. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n3. Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,\n4. Participation to a study involving a medical or therapeutic intervention in the last 28 days,\n5. Known infection with HIV, hepatitis B, or hepatitis C,\n6. Females who are pregnant or breast-feeding,\n7. Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,\n8. Individuals deprived of liberty or placed under legal guardianship,\n9. Unwillingness or inability to comply with the study protocol for any reason.\n\nAdditional criteria for randomization :\n\n1. High-risk CINSARC signature,\n2. No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before randomization.","ALL","18 Years",{"count":20,"type":21},351,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +\u002F- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).",[27,28],"Non-metastatic Soft-tissue Sarcoma","Resectable",[30,31,32,28,33],"Solid tumor","Phase III trial","Soft-tissue sarcoma","Non-metastatic","RECRUITING","2025-10-01",{"date":37,"type":38},"2025-10-02","ACTUAL",{"date":40,"type":38},"2019-02-14",{"date":42,"type":21},"2028-12",{"name":44,"class":45},"Institut Bergonié","OTHER",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100587060","phase-2-neoadjuvant-gemcitabine-and-cisplatin-in-combination-with-perioperative-pembrolizumab-versus-upfront-surgery-for-patients-with-primary-resectable-and-borderline-resectable-perihilar-and-distal-cholangiocarcinoma-100587060","NCT06923475","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma (NEODISCO): A Multicentre Phase 2B\u002F3 Randomized Controlled Trial","NEODISCO","Inclusion Criteria:\n\n* Histologically or cytologically confirmed resectable or borderline resectable pCCA and dCCA. These are all the patients considered candidates for upfront surgical exploration, with intent to resect, as confirmed by local MDT and the study expert panel also taking into consideration endoscopic and radiological findings. In cases where drainage is not required, patients with a disease highly suspicious for extrahepatic cholangiocarcinoma, as determined by the expert MDT, may be included without histological proof to prevent unnecessary post-ERCP complications.\n* Successful drainage, in case of clinical significant bile duct obstruction.\n* MidCCA inclusion in the NEODISCO-trial will be permitted and will be included according to the proposed type of resection.\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n\nExclusion Criteria:\n\n* Upfront \"clearly\" unresectable pCCA: circumferential unreconstructable vascular involvement of the FLR and\u002For insufficient FLR for potential radical resection. Insufficient FLR is defined as \\\u003C30% residual volume or a function \\\u003C2.7 min\u002Fm2. Patients considered borderline resectable but, by the discretion of the MDT, not a candidate for upfront exploration\u002Fresection, are considered ineligible for NEODISCO.\n* Upfront clearly unresectable dCCA (following DPCG criteria).\n* Patients with proven N2 lymph nodes (according to the AJCC 8th edition).\n* PCCA eligible for liver transplantation.\n* Intrahepatic cholangiocarcinoma with hilar involvement.\n* Cancer suspicious for ampullary carcinoma (for instance involvement of papilla during endoscopy).\n* Local recurrence following prior resection of eCCA (patients who develop local recurrence during the study are however not excluded).\n* Patients with underlying liver diseases: PSC, untreated hepatitis, cirrhosis child-Pugh B, C.\n* Previous malignancy unless no evidence of disease, or diagnosed more than 3 years before diagnosis of eCCA, or with a life expectancy of more than 5 years from date of inclusion.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).",{"count":56,"type":21},150,[58,24],"PHASE2","Extrahepatic cholangiocarcinoma (eCCA) is a rare and aggressive cancer with poor prognosis. ECCA can be further subcategorised in perihilar and distal cholangiocarcinoma (pCCA and dCCA). Surgical resection is the only potential cure, but only one-third of patients are eligible. Even among those deemed resectable, a significant portion (≈30%) experience disease progression before surgery, while another 30% are found unresectable during exploration. High recurrence rates and postoperative complications further limit survival, with 5-year overall survival ranging from 13% (R1 resection) to 40% (R0 resection). Given the long preoperative work-up period and lack of treatment during this phase, a neoadjuvant approach may improve outcomes by increasing R0 resections, reducing recurrence, and optimizing patient selection.\n\nThis multicenter, randomized phase 2B\u002F3 trial aims to assess whether neoadjuvant gemcitabine and cisplatin plus perioperative pembrolizumab improves event-free survival in patients with resectable and borderline resectable pCCA and dCCA.",[61,62,63,28,64],"Extrahepatic Cholangiocarcinoma","Perihilar Cholangiocarcinoma","Distal Cholangiocarcinoma","Borderline Resectable",[66,62,63,28,67],"Extrahepatic cholangiocarcinoma","Borderline resectable","NOT_YET_RECRUITING","2025-04-03",{"date":71,"type":38},"2025-04-11",{"date":73,"type":21},"2025-05-05",{"date":75,"type":21},"2028-11-06",{"name":77,"class":45},"Amsterdam UMC, location VUmc",1]