NIPH Clinical Trials Search

UMIN ID: C000000385

Registered date:01/04/2006

A randomized controlled study comparing S-1 with UFT as postoperative adjuvant Chemotherapy in Rectal Cancer.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRectal Cancer
Date of first enrollment2006/04/01
Target sample size800
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Group A (standard therapy group): UFT (400 mg/m2/day) is administered orally on days 1-5 of every week for 1 year. Group B (trial therapy group): S-1 (80 mg/m2/day) is administered orally for 28 consecutive days repeated every 42 days for 1 year.


Primary OutcomeRelapse - free survival (RFS)
Secondary OutcomeOverall survival (OS), Adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria1) Histologically confirmed rectal adenocarcinoma (exclude Rs) 2) Histological Stage IIA, IIB, IIIA, IIIB, IIIC located 3) No synchronous colorectal cancer which invade submucosa or deeper 4) Curative resection with lymph node dissection 5) Resection of histological curability A was performed 6) No prior therapy 7) Within 42 days after the operation 8) Oral intake is possible 9) Sufficient organ functions a. WBC >= 3,500/mm3 b. Hemoglobin >= 9g/dL c. Platelet >= 100,000/mm3 d. Total bilirubin <= 1.2mg/dL e. AST, ALT < 100IU/L f. Serum creatinine <= 1.0mg/dL 10) Written informed consent
Exclude criteria1) Anal gland derived cancer of anal canal 2) Active synchronous or metachronous malignancy other than carcinoma in situ 3) Serious postoperative complications 4) Serious coexisting illness a. interstitial pneumonia, pulmonary fibrosis b. intestinal paralysis or obstruction c. uncontrolled diabetes mellitus d. hepatic cirrhosis e. hepatic failure f. renal failure g. uncontrolled hypertension h. history of myocardial infarction, unstable angina within 6 months prior to the registration 5) Limitation of use of UFT or TS-1 6) Under treatment with flucytosine, phenytoin, or warfarin 7) Episode of drug allergy reaching grade 3 or more severe 8) Pregnant or nursing 9) Severe mental disorders 10) Positive HIV 11) 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 Yoshihiko Maehara
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan Japan
Affiliation Graduate School of Medical Sciences, Kyushu University Department of Surgery and Science