{"id":"tegafur-uracil-uft","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Diarrhea"},{"rate":"10-20%","effect":"Nausea"},{"rate":"5-10%","effect":"Vomiting"},{"rate":"5-10%","effect":"Fatigue"},{"rate":"5-10%","effect":"Anemia"}]},"_chembl":{"chemblId":"CHEMBL235993","moleculeType":"Small molecule","molecularWeight":"200.17"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This inhibition of thymidylate synthase leads to a decrease in DNA synthesis and cell proliferation, ultimately resulting in cell death. 5-FU is a pyrimidine analog that is incorporated into DNA, causing strand breaks and apoptosis. The uracil component of UFT helps to maintain a steady level of 5-FU in the body by inhibiting its degradation.","oneSentence":"Tegafur-uracil (UFT) is a prodrug that is metabolized into 5-fluorouracil (5-FU), which then inhibits thymidylate synthase.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:37:51.452Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Colorectal cancer"}]},"trialDetails":[{"nctId":"NCT00905047","phase":"PHASE3","title":"Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Centre Oscar Lambret","startDate":"2005-11-14","conditions":"Colorectal Cancer","enrollment":89},{"nctId":"NCT07372300","phase":"PHASE3","title":"Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer","status":"RECRUITING","sponsor":"Shih-Kai Hung","startDate":"2025-09-23","conditions":"Locally Advanced Rectal Carcinoma","enrollment":126},{"nctId":"NCT02363400","phase":"PHASE3","title":"A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA","status":"TERMINATED","sponsor":"National Health Research Institutes, Taiwan","startDate":"2014-12-14","conditions":"Nasopharyngeal Carcinoma","enrollment":10},{"nctId":"NCT01720563","phase":"PHASE2","title":"A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy","status":"TERMINATED","sponsor":"PhytoHealth Corporation","startDate":"2012-12","conditions":"Cancer-related Fatigue","enrollment":17},{"nctId":"NCT00004860","phase":"PHASE2","title":"Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Eastern Cooperative Oncology Group","startDate":"2000-10-09","conditions":"Colorectal Cancer","enrollment":""},{"nctId":"NCT00207831","phase":"PHASE3","title":"Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma","status":"TERMINATED","sponsor":"Institut Cancerologie de l'Ouest","startDate":"2004-07","conditions":"Rectal Cancer, Stage II/III, T3 or T4 (Only Anal Extension) Rectal Cancer","enrollment":219},{"nctId":"NCT03811652","phase":"PHASE1","title":"A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2018-12-20","conditions":"Non Small Cell Lung Cancer Squamous (NSCLC-Sq), Head and Neck Squamous Cell Carcinoma (HNSCC), Small Cell Lung Cancer (SCLC)","enrollment":8},{"nctId":"NCT03121313","phase":"PHASE2","title":"Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2015-02-26","conditions":"Squamous Cell Carcinoma of Oral Cavity","enrollment":68},{"nctId":"NCT03161548","phase":"PHASE2","title":"A Study of Tongue Conservation Surgery for Oral Tongue Cancer","status":"TERMINATED","sponsor":"Taipei Veterans General Hospital, Taiwan","startDate":"2011-07-18","conditions":"Tongue Cancer, Chemotherapy Effect, Surgery","enrollment":23},{"nctId":"NCT02836977","phase":"NA","title":"Maintenance Tegafur-uracil Versus Observation Following Adjuvant Oxaliplatin-based Regimen in Patients With Stage III Colon Cancer After Radical Resection","status":"UNKNOWN","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","startDate":"2016-03","conditions":"Stage III Colon Cancer","enrollment":400},{"nctId":"NCT02447679","phase":"PHASE2","title":"Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2010-08","conditions":"Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Adverse Reaction to Drug","enrollment":40},{"nctId":"NCT01050426","phase":"PHASE2","title":"A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)","status":"TERMINATED","sponsor":"Royal Marsden NHS Foundation Trust","startDate":"2009-03","conditions":"Pancreatic Cancer","enrollment":17},{"nctId":"NCT02903498","phase":"PHASE2","title":"The Maintenance Treatment of UFT in Advanced Gastric Cancer","status":"COMPLETED","sponsor":"Fudan University","startDate":"2009-08","conditions":"Gastric Cancer","enrollment":58},{"nctId":"NCT00392899","phase":"PHASE3","title":"Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery","status":"COMPLETED","sponsor":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan","startDate":"2006-10","conditions":"Colorectal Cancer","enrollment":2025},{"nctId":"NCT00898846","phase":"","title":"Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery","status":"COMPLETED","sponsor":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan","startDate":"2006-10","conditions":"Colorectal Cancer","enrollment":1111},{"nctId":"NCT02887365","phase":"PHASE4","title":"A Phase II Study of Tegafur-Uracil as Maintenance Chemotherapy in Patients With Stage II of Colon Cancer","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2014-09","conditions":"MSI-L/MSS, Stage II Colon Cancer","enrollment":300},{"nctId":"NCT00660894","phase":"PHASE3","title":"Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery","status":"COMPLETED","sponsor":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan","startDate":"2008-04","conditions":"Colorectal Cancer","enrollment":1535},{"nctId":"NCT01539018","phase":"PHASE2","title":"Sorafenib Plus Tegafur-uracil (UFT) Versus Sorafenib as First Line Systemic Treatment for Patients With Advanced Stage HCC, Unresectable & Not Eligible for Local Ablation and/or TACE","status":"TERMINATED","sponsor":"Egyptian Society of Liver Cancer","startDate":"2012-01","conditions":"Advanced Hepatocellular Carcinoma","enrollment":77},{"nctId":"NCT01262274","phase":"PHASE2","title":"Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer","status":"TERMINATED","sponsor":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan","startDate":"2010-12","conditions":"Breast Neoplasms","enrollment":57},{"nctId":"NCT00439517","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2007-02","conditions":"Previously Untreated Metastatic Colorectal Cancer","enrollment":302},{"nctId":"NCT01225744","phase":"PHASE2","title":"Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy","status":"COMPLETED","sponsor":"The Christie NHS Foundation Trust","startDate":"2009-04","conditions":"Metastatic Colorectal Cancer","enrollment":47},{"nctId":"NCT00002801","phase":"PHASE1","title":"Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"1996-04","conditions":"Colorectal Cancer","enrollment":30},{"nctId":"NCT00009815","phase":"PHASE1","title":"Combination Chemotherapy in Treating Patients With Advanced Solid Tumors","status":"WITHDRAWN","sponsor":"University of Pittsburgh","startDate":"1999-12","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","enrollment":""},{"nctId":"NCT00009828","phase":"PHASE1","title":"Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors","status":"WITHDRAWN","sponsor":"University of Pittsburgh","startDate":"1999-12","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","enrollment":""},{"nctId":"NCT00336947","phase":"PHASE3","title":"S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer","status":"UNKNOWN","sponsor":"Yokohama City University","startDate":"2006-04","conditions":"Head and Neck Cancer","enrollment":500},{"nctId":"NCT00003925","phase":"PHASE1","title":"Combination Chemotherapy In Treating Patients With Advanced Cancer","status":"COMPLETED","sponsor":"Barbara Ann Karmanos Cancer Institute","startDate":"1998-05","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","enrollment":36},{"nctId":"NCT00385970","phase":"PHASE3","title":"A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer","status":"UNKNOWN","sponsor":"Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group","startDate":"2006-03","conditions":"Colorectal Cancer","enrollment":380},{"nctId":"NCT00005608","phase":"PHASE2","title":"Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer","status":"TERMINATED","sponsor":"Northwestern University","startDate":"2000-02","conditions":"Breast Cancer","enrollment":""},{"nctId":"NCT00519688","phase":"PHASE2","title":"UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2006-07","conditions":"Hepatocellular Carcinoma","enrollment":44},{"nctId":"NCT00855881","phase":"PHASE2","title":"Metronomic Chemotherapy With Tegafur/Uracil for Head and Neck Squamous Cell Carcinoma","status":"UNKNOWN","sponsor":"Mackay Memorial Hospital","startDate":"2008-12","conditions":"Head and Neck Cancer","enrollment":115},{"nctId":"NCT00152191","phase":"PHASE3","title":"A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)","status":"COMPLETED","sponsor":"Taiho Pharmaceutical Co., Ltd.","startDate":"1996-10","conditions":"Breast Cancer","enrollment":1300},{"nctId":"NCT00152178","phase":"PHASE3","title":"The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)","status":"COMPLETED","sponsor":"Taiho Pharmaceutical Co., Ltd.","startDate":"1996-07","conditions":"Breast Cancer","enrollment":680},{"nctId":"NCT00152230","phase":"PHASE3","title":"A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)","status":"COMPLETED","sponsor":"Taiho Pharmaceutical Co., Ltd.","startDate":"1996-10","conditions":"Colorectal Cancer","enrollment":900},{"nctId":"NCT00152243","phase":"PHASE3","title":"A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)","status":"COMPLETED","sponsor":"Taiho Pharmaceutical Co., Ltd.","startDate":"1997-06","conditions":"Gastric Cancer","enrollment":500},{"nctId":"NCT01082510","phase":"PHASE3","title":"Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)","status":"UNKNOWN","sponsor":"Urological Oncology Council of Northern Tokyo","startDate":"2010-01","conditions":"Bladder Cancer","enrollment":288},{"nctId":"NCT00209742","phase":"PHASE3","title":"Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer","status":"UNKNOWN","sponsor":"Hokkaido Gastrointestinal Cancer Study Group","startDate":"2005-04","conditions":"Colorectal Cancer","enrollment":340},{"nctId":"NCT00378716","phase":"PHASE3","title":"Combination Chemotherapy in Treating Patients With Resected Colon Cancer","status":"COMPLETED","sponsor":"NSABP Foundation Inc","startDate":"1997-02","conditions":"Colorectal Cancer","enrollment":1608},{"nctId":"NCT00677612","phase":"PHASE1, PHASE2","title":"Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer","status":"TERMINATED","sponsor":"Tokyo University","startDate":"2008-05","conditions":"Colorectal Cancer, Colon Cancer, Rectal Cancer","enrollment":14},{"nctId":"NCT00677287","phase":"PHASE1, PHASE2","title":"Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer","status":"TERMINATED","sponsor":"Tokyo University","startDate":"2008-05","conditions":"Colorectal Cancer, Colon Cancer, Rectal Cancer","enrollment":14},{"nctId":"NCT01037998","phase":"PHASE2","title":"UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer","status":"COMPLETED","sponsor":"Taipei Veterans General Hospital, Taiwan","startDate":"2005-11","conditions":"Non-Small-Cell Lung Cancer","enrollment":115},{"nctId":"NCT00464919","phase":"PHASE2","title":"Sorafenib Plus Tegafur/Uracil (UFUR®) for Hepatocellular Carcinoma (HCC)","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2007-04","conditions":"Hepatocellular Carcinoma","enrollment":50},{"nctId":"NCT00890188","phase":"PHASE2","title":"Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer","status":"UNKNOWN","sponsor":"National Cheng-Kung University Hospital","startDate":"2009-01","conditions":"Colon Cancer","enrollment":34},{"nctId":"NCT00384800","phase":"PHASE2","title":"A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC)","status":"UNKNOWN","sponsor":"Far Eastern Memorial Hospital","startDate":"2006-09","conditions":"Carcinoma, Hepatocellular","enrollment":41},{"nctId":"NCT00497107","phase":"PHASE3","title":"Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer","status":"UNKNOWN","sponsor":"Iwate Medical University","startDate":"2007-07","conditions":"Colorectal Cancer","enrollment":300},{"nctId":"NCT00625352","phase":"PHASE2","title":"Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma","status":"UNKNOWN","sponsor":"Ulsan University Hospital","startDate":"2008-02","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":48},{"nctId":"NCT00139971","phase":"PHASE3","title":"Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer","status":"UNKNOWN","sponsor":"West Japan Thoracic Oncology Group","startDate":"2001-12","conditions":"Lung Cancer","enrollment":600},{"nctId":"NCT00037089","phase":"PHASE2","title":"A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer","status":"UNKNOWN","sponsor":"Edelman, Martin, M.D.","startDate":"","conditions":"Esophageal Neoplasm","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"BONE MARROW FAILURE"},{"count":1,"reaction":"DEHYDRATION"},{"count":1,"reaction":"DEPRESSED LEVEL OF CONSCIOUSNESS"},{"count":1,"reaction":"DISEASE PROGRESSION"},{"count":1,"reaction":"ERYTHEMA"},{"count":1,"reaction":"EXTRAVASATION"},{"count":1,"reaction":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"count":1,"reaction":"HYPERSENSITIVITY"},{"count":1,"reaction":"PRURITUS"},{"count":1,"reaction":"RASH"}],"_approvalHistory":[],"publicationCount":184,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["UFT"],"phase":"phase_3","status":"active","brandName":"Tegafur-uracil (UFT)","genericName":"Tegafur-uracil (UFT)","companyName":"Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group","companyId":"multicenter-clinical-study-group-of-osaka-colorectal-cancer-treatment-group","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tegafur-uracil (UFT) is a small molecule used in the treatment of Colorectal Cancer and Hepatocellular Carcinoma. It is often combined with other interventions, such as Calcium folinate (LV) and Krestin (PSK), in clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}