{"id":"arm-b-folfiri-or-folfox","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Neutropenia"},{"rate":"40-50","effect":"Diarrhea"},{"rate":"30-40","effect":"Nausea/vomiting"},{"rate":"30-40","effect":"Anemia"},{"rate":"20-30","effect":"Mucositis"},{"rate":"20-30","effect":"Peripheral neuropathy (oxaliplatin)"},{"rate":"30-40","effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FOLFIRI combines fluorouracil (5-FU), leucovorin, and irinotecan (a topoisomerase I inhibitor that prevents DNA unwinding and repair). FOLFOX combines fluorouracil, leucovorin, and oxaliplatin (a platinum agent causing DNA cross-links). Both regimens are standard chemotherapy backbones for colorectal cancer that work through distinct mechanisms of DNA damage and inhibition of nucleotide synthesis.","oneSentence":"FOLFIRI and FOLFOX are combination chemotherapy regimens that inhibit DNA synthesis and cell division through fluorouracil-based cytotoxic activity, with irinotecan targeting topoisomerase I or oxaliplatin targeting DNA cross-linking.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:02:28.053Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic colorectal cancer"},{"name":"Adjuvant treatment of stage III colorectal cancer"}]},"trialDetails":[{"nctId":"NCT07221357","phase":"PHASE2, PHASE3","title":"A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-12-31","conditions":"Untreated, Unresectable, or Metastatic Colorectal Cancer","enrollment":990},{"nctId":"NCT05863195","phase":"PHASE3","title":"Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial","status":"RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2023-10-19","conditions":"Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8","enrollment":408},{"nctId":"NCT06663319","phase":"PHASE1","title":"A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2024-10-15","conditions":"Colorectal Neoplasms, Gastrointestinal Neoplasms","enrollment":220},{"nctId":"NCT06937905","phase":"PHASE3","title":"Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)","status":"RECRUITING","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","startDate":"2026-02-06","conditions":"Neuroendocrine Carcinoma","enrollment":129},{"nctId":"NCT00208260","phase":"PHASE2, PHASE3","title":"Intensified Chemotherapy in CRC After Resection of Liver Metastases","status":"COMPLETED","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","startDate":"2004-04","conditions":"Colorectal Cancer, Liver Metastases, Chemotherapy","enrollment":124},{"nctId":"NCT07389265","phase":"PHASE3","title":"Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2025-10-01","conditions":"Metastatic Colorectal Cancer (mCRC)","enrollment":480},{"nctId":"NCT07150403","phase":"PHASE2","title":"Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"Federation Francophone de Cancerologie Digestive","startDate":"2025-12-31","conditions":"Metastatic Colorectal Carcinoma (mCRC)","enrollment":74},{"nctId":"NCT03186326","phase":"PHASE2","title":"Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer","status":"COMPLETED","sponsor":"Federation Francophone de Cancerologie Digestive","startDate":"2018-04-24","conditions":"Metastatic Colorectal Cancer, MSI","enrollment":132},{"nctId":"NCT06857773","phase":"PHASE3","title":"Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy","status":"RECRUITING","sponsor":"The Netherlands Cancer Institute","startDate":"2024-11-21","conditions":"Colorectal Neoplasms, Floxuridine, Liver Metastases","enrollment":306},{"nctId":"NCT02162563","phase":"PHASE3","title":"Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases","status":"COMPLETED","sponsor":"Dutch Colorectal Cancer Group","startDate":"2014-07","conditions":"Colorectal Cancer, Liver Metastases","enrollment":530},{"nctId":"NCT03117972","phase":"PHASE2","title":"Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels","status":"TERMINATED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2017-08-04","conditions":"Metastatic Colorectal Cancer","enrollment":54},{"nctId":"NCT01878422","phase":"PHASE3","title":"Sequential Treatment Strategy for Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2007-11","conditions":"Metastatic Colorectal Cancer","enrollment":376},{"nctId":"NCT01442935","phase":"PHASE2","title":"Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases","status":"COMPLETED","sponsor":"UNICANCER","startDate":"2011-02","conditions":"Colorectal Cancer","enrollment":256},{"nctId":"NCT02015923","phase":"PHASE4","title":"Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases","status":"TERMINATED","sponsor":"Hospital Universitari de Bellvitge","startDate":"2013-12","conditions":"Colonic Cancer, Unresectable Metastasis Originating in Colonic Cancer","enrollment":107},{"nctId":"NCT01280643","phase":"NA","title":"Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer","status":"TERMINATED","sponsor":"Fox Chase Cancer Center","startDate":"2010-03","conditions":"Metastatic Colorectal Cancer","enrollment":3},{"nctId":"NCT01896869","phase":"PHASE2","title":"FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2013-11","conditions":"Metastatic Pancreatic Adenocarcinoma","enrollment":83},{"nctId":"NCT00265850","phase":"PHASE3","title":"Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2005-11","conditions":"Colorectal Cancer","enrollment":2334},{"nctId":"NCT00077233","phase":"PHASE3","title":"FOLFIRI or FOLFOX With or Without Cetuximab in Patients With Metastatic Adenocarcinoma of the Colon or Rectum","status":"TERMINATED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2003-12","conditions":"Colorectal Cancer","enrollment":238},{"nctId":"NCT01765582","phase":"PHASE2","title":"Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer","status":"TERMINATED","sponsor":"Hoffmann-La Roche","startDate":"2013-01-23","conditions":"Colorectal Neoplasms","enrollment":280},{"nctId":"NCT02109341","phase":"PHASE1, PHASE2","title":"Phase I/II Study to Evaluate Nab-paclitaxel in Substitution of CPT11 or Oxaliplatin in FOLFIRINOX Schedule as First Line Treatment in Metastatic Pancreatic Cancer","status":"COMPLETED","sponsor":"Gruppo Oncologico Italiano di Ricerca Clinica","startDate":"2014-02","conditions":"Metastatic Pancreatic Cancer","enrollment":148},{"nctId":"NCT01454180","phase":"PHASE2","title":"Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets","status":"COMPLETED","sponsor":"Centro Nacional de Investigaciones Oncologicas CARLOS III","startDate":"2011-10","conditions":"Advanced Pancreatic Carcinoma","enrollment":31},{"nctId":"NCT01564810","phase":"PHASE4","title":"Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer","status":"UNKNOWN","sponsor":"Xu jianmin","startDate":"2006-09","conditions":"Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms","enrollment":150}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3256,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Arm C: FOLFIRI or FOLFOX"],"phase":"phase_3","status":"active","brandName":"Arm B: FOLFIRI or FOLFOX","genericName":"Arm B: FOLFIRI or FOLFOX","companyName":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. 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