Status:
COMPLETED
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from divid...
Detailed Description
OBJECTIVES: * Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin after curative surgery . OUTLINE: Patients are randomized to...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of colon
- Stage III (T1-4, N1-3, M0) disease
- Has undergone surgical resection of the tumor within the past 8 weeks
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Able to take medications orally
- WBC ≥ 3,500/mm³ and \< 12,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 2.0 mg/dL
- AST/ALT ≤ 100 IU/L
- Creatinine ≤ 1.2 mg/dL
- No other active malignancies
- Must have none of the following comorbidities:
- Severe postoperative complications
- Uncontrollable diabetes mellitus
- Uncontrollable hypertension
- Myocardial infraction within 6 months
- Unstable angina pectoris
- Hepatocirrhosis
- Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for colon cancer
- No concurrent radiotherapy
- No concurrent biological response modifiers
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
1535 Patients enrolled
Trial Details
Trial ID
NCT00660894
Start Date
April 1 2008
End Date
July 1 2015
Last Update
August 3 2016
Active Locations (1)
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1
Tokyo Medical and Dental University
Tokyo, Tokyo, Japan, 113-8519