NIPH Clinical Trials Search

UMIN ID: C000000245

Registered date:22/09/2005

Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedcolorectal cancer
Date of first enrollment2005/10/01
Target sample size840
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Group A (standard therapy group): Administration of 5 courses (6 months) of a schedule (consecutive administration method) in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. Group B (trial therapy group): Administration of 15 courses (18 months) of a schedule (5 days on, 2 days off: Saturday and Sunday) in which one course consists of 5 weeks of UFT (300 mg/m2/day) and LV (75 mg/day) for 5 consecutive days followed by 2 days off.


Primary Outcomedisease-free survival
Secondary Outcomeoverall survival, incidence of adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1) Histologically confirmed colorectal cancer 2) Histological Stage IIB, IIIA, IIIB, IIIC located in colon and rectosigmoid 3) Curative resection with D2 or more lymph node dissection 4) Resection of histological curability A was performed 5) Performance status (ECOG) 0, 1 6) No prior chemotherapy and radiotherapy 7) Oral intake is possible 8) Sufficient organ functions a) WBC >= 3,000/mm3, <12,000/mm3 b) Neutrophil >=1,500/mm3 c) Hemoglobin >= 9.0g/dL d) Platelet >= 100,000/mm3 e) Total bilirubin < 1.5mg/dL f) AST, ALT < 100IU/L g) Serum creatinine < 1.5mg/dL 9) Chemotherapy will be started within 6 weeks from operation 10) Written informed consent
Exclude criteria1) active synchronous or metachronous malignancy other than carcinoma in situ 2) serious coexisting illness a; severe pulmonary dysfunction b; ileus or colon dysfunction c; uncontrolled diabetes mellitus d; liver cirrhosis e; uncontrolled hypertension f; history of myocardial infarction, unstable angina within 6 months prior to the registration 3) pregnant or nursing 4) severe mental disorders 5) not suitable for participating in the study for any other reason

Related Information


public contact
Name Japanese Foundation for Multidisciplinary Treatment of Cancer
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
Affiliation Japanese Foundation for Multidisciplinary Treatment of Cancer Office
scientific contact
Name Susumu Kodaira
Address 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8606, Japan Japan
Affiliation Teikyo University Visiting Professor