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

UMIN ID: C000000385

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Rectal Cancer
• Date of first enrollment: 2006/04/01
• Target sample size: 800
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Relapse - free survival (RFS)
• Secondary Outcome: Overall survival (OS), Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Taiho Pharmaceutical Co., Ltd.