[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444313":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":153,"collaborators":25,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":25,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Institut du Cancer de Montpellier - Val d'Aurelle","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GEMBRAX\u002FFOLFIRINOX Arm A","EXPERIMENTAL","One cycle:\n\n* D1, D8 and D15 GEMBRAX: Albumin bound paclitaxel 125mg \u002F m² followed by Gemcitabine 1000mg \u002F m² followed by 2 weeks of rest\n* D29 and D43 FOLFIRINOX: Oxaliplatin 85mg \u002F m², Irinotecan 180mg \u002F m², Folinic acid 400 mg \u002F m², 5-fluorouracil 400mg \u002F m² in bolus followed by continuous administration over 46h at 2400mg \u002F m² followed by 2 weeks of rest.\n\nA maximum of 6 cycles (12 months) of chemotherapy will be administered to patients in arm A.",[13],"Combination Product: GEMBRAX\u002FFOLFIRINOX Arm A",{"label":15,"type":16,"description":17,"interventionNames":18},"FOLFIRINOX Arm B","ACTIVE_COMPARATOR","One cycle :\n\nD1, D15, D29 and D43 FOLFIRINOX: Oxaliplatin 85mg \u002F m², Irinotecan 180mg \u002F m², Folinic acid 400mg \u002F m², 5-fluorouracil 400mg \u002F m² as a bolus followed by continuous administration over 46h at 2.400mg \u002F m² followed by 2 weeks of rest.\n\nA maximum of 3 cycles (6 months) of chemotherapy will be administered to patients in arm B.",[19],"Combination Product: FOLFIRINOX Arm B",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Patients in the experimental arm received sequential treatment: A maximum of 6 cycles (12 months) of chemotherapy; One cycle = 3 administrations of GEMBRAX followed by 2 administrations of FOLFIRINOX",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX",[15],[30],{"name":31,"affiliation":32,"role":33},"Fabienne PORTALES, MD","Institut de Cancérologie de Montpellier (ICM)","STUDY_CHAIR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Aurore MOUSSION, MD","CONTACT","0467612446","+33","Aurore.Moussion@icm.unicancer.fr",{"name":31,"role":37,"phone":42,"phoneExt":39,"email":43},"0467612353","Fabienne.Portales@icm.unicancer.fr",[45,63,73,88,103,116,130,140],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CHU Grenoble","NOT_YET_RECRUITING","Grenoble","Auvergne-Rhône-Alpes","38000","France","FR",{"type":54,"coordinates":55},"Point",[56,57],5.71479,45.17869,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":25,"phoneExt":25,"email":62},"Gael ROTH, MD","GRoth@chu-grenoble.fr",{"facility":64,"status":65,"city":66,"state":49,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":25},"CHU St Etienne","ACTIVE_NOT_RECRUITING","Saint-Etienne","42000",{"type":54,"coordinates":69},[70,71],4.39,45.43389,{"lat":71,"lon":70},{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":51,"countryCode":52,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Institut GODINOT","RECRUITING","Reims","Grand Est","51100",{"type":54,"coordinates":80},[81,82],4.02853,49.26526,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":25,"phoneExt":25,"email":87},"Damien BOTSEN, MD","damien.botsen@reims.unicancer.fr",{"facility":89,"status":75,"city":90,"state":91,"zip":92,"country":51,"countryCode":52,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"CHU St Eloi","Montpellier","Herault","34295",{"type":54,"coordinates":94},[95,96],3.87635,43.61093,{"lat":96,"lon":95},[99],{"name":100,"role":37,"phone":101,"phoneExt":25,"email":102},"Eric Assénat, MD","04 67 33 67 33","e-assenat@chu-montpellier.fr",{"facility":104,"status":75,"city":90,"state":105,"zip":106,"country":51,"countryCode":52,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Institut régional du Cancer de Montpellier","Hérault","34298",{"type":54,"coordinates":108},[95,96],{"lat":96,"lon":95},[111,113],{"name":112,"role":37,"phone":25,"phoneExt":25,"email":25},"Aurore MOUSSION",{"name":114,"role":115,"phone":25,"phoneExt":25,"email":25},"Fabienne Portalès, MD","PRINCIPAL_INVESTIGATOR",{"facility":117,"status":47,"city":118,"state":119,"zip":120,"country":51,"countryCode":52,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Centre Catalan d'Oncologie","Perpignan","Pyrénées-Orientales","66000",{"type":54,"coordinates":122},[123,124],2.89541,42.69764,{"lat":124,"lon":123},[127],{"name":128,"role":37,"phone":25,"phoneExt":25,"email":129},"Fawzi KARA-SLIMANE, MD","fawzi.karaslimane@cco-perpignan.fr",{"facility":131,"status":75,"city":118,"state":119,"zip":132,"country":51,"countryCode":52,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"CH de Perpignan","66046",{"type":54,"coordinates":134},[123,124],{"lat":124,"lon":123},[137],{"name":138,"role":37,"phone":25,"phoneExt":25,"email":139},"Faiza KHEMISSA, MD","faiza.khemissa@ch-perpignan.fr",{"facility":141,"status":75,"city":142,"state":25,"zip":143,"country":51,"countryCode":52,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Centre Georges-François Leclerc","Dijon","21079",{"type":54,"coordinates":145},[146,147],5.01391,47.31344,{"lat":147,"lon":146},[150],{"name":151,"role":37,"phone":25,"phoneExt":25,"email":152},"François Ghiringhelli, MD","FGhiringhelli@cgfl.fr",{"type":154,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100444313","phase-2-efficacy-of-gembrax-followed-by-folfirinox-versus-folfirinox-alone-in-first-metastatic-line-pancreatic-cancer-patients-100444313",false,"NCT05065801","Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients","Randomized Phase II Trial Evaluating the Efficacy of a Sequential Treatment Gemcitabine Plus Nab-paclitaxel (Gembrax) Followed by Folfirinox Versus Folfirinox Alone in Patients Treated in First Metastatic Line Pancreatic Cancer","GABRINOX2","Inclusion Criteria:\n\n1. Male or female aged 18 to 75 on the date the consent is signed.\n2. Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data.\n3. One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast).\n4. Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected.\n5. WHO performance status ≤ 1\n6. Uracilemia \\\u003C16 ng \u002F ml\n7. Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by: • Neutrophils ≥ 2 × 109 \u002F L; • Platelets ≥ 100,000 \u002F mm3 (100 × 109 \u002F L); • Hemoglobin ≥ 9 g \u002F dl.\n8. Acceptable renal and hepatic function at inclusion (obtained within 14 days before the start of treatment) defined by: • AST and ALT ≤ 2.5 x upper limit of the norm (ULN), unless liver metastases are present in this case AST and ALT ≤ 5 × ULN is allowed; • Total bilirubin ≤ 1.5 x ULN; • Serum creatinine within the norm limits or calculated clearance ≥ 50ml \u002F min for patients with a serum creatinine value above or below the norm values (clearance calculated by the CKD-EPI formula).\n9. Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN\n10. If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of administration of the study drug and up to 6 months after discontinuation of treatment for women and for men.\n11. Signature of consent before any procedure specific to the study.\n12. Affiliated with the French national social security.\n\nExclusion Criteria:\n\n1. Known brain metastasis.\n2. Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.\n3. Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment.\n4. Known Gilbert's syndrome or homozygous for know UGT1A1 \\* 28\n5. Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated curatively without chemotherapy and without any sign of disease in the 3 years preceding inclusion.\n6. Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months.\n7. Peripheral sensory neuropathy ≥ grade 2 at the time of inclusion.\n8. ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women\n9. Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders)\n10. Allergy or intolerance to any study drug (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or any excipient (e.g., fructose) as described in the sections \" contraindication or special warnings and precautions\" or \"prescribing information\" of the summary of product characteristics indications.\n11. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test (serum β-hCG) within 72 hours prior to inclusion.\n12. Patients on vitamin K antagonists (e.g., Coumadin) (modifications to treatment may be required prior to inclusion).\n13. Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction).\n14. Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment.\n15. Active HIV infection, known hepatitis B or C infection.\n16. History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia.\n17. Administration of a live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment.\n18. Patient refusal or inability to comply with study procedures.\n19. Inability to undergo follow-up for geographical, social, or psychological reasons.\n20. Participation in another clinical trial involving an investigational product within the 30 days prior to inclusion.\n21. Legal incapacity (patient under guardianship or guardianship).","ALL","18 Years","75 Years",{"count":167,"type":168},162,"ESTIMATED","INTERVENTIONAL",[171],"PHASE2","The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer",[174],"Metastatic Pancreatic Cancer",[176,177],"pancreatic","cancer","2026-04-10",{"date":180,"type":181},"2026-04-15","ACTUAL",{"date":183,"type":181},"2022-01-11",{"date":185,"type":168},"2028-06-30",{"name":5,"class":6},8]