A randomized controlled study comparing S-1 with UFT as postoperative adjuvant Chemotherapy in Rectal Cancer.
- Conditions
- Rectal Cancer
- Registration Number
- JPRN-C000000385
- Lead Sponsor
- Japanese Foundation for Multidisciplinary Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 800
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse - free survival (RFS)
- Secondary Outcome Measures
Name Time Method Overall survival (OS), Adverse events