Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
20 Years
80 Years
Both
Colorectal Cancer
Trial Information
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with
curatively resected stage II colorectal cancer.
Secondary
- Compare relapse-free and overall survival of patients treated with these regimens.
- Compare the occurrence of adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients undergo observation.
- Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7
days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectosigmoid
- Stage II disease
- Has undergone curative (R0) resection within the past 8 weeks
- No suspicion of hereditary colorectal cancer
- No severe postoperative complications
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC 3,500-12,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 100 IU/L
- Creatinine ≤ 1.5 mg/dL
- Not pregnant or nursing
- Able to take oral medications
- Major organ functions are preserved
- No other active malignancy
- None of the following conditions:
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Myocardial infarction or unstable angina pectoris within the past 6 months
- Liver cirrhosis
- Interstitial pneumonia
- Pulmonary fibrosis
- Severe emphysema
- No psychiatric disease or other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
- No prior or concurrent radiotherapy
- No concurrent prophylactic growth factors
- No concurrent biologic response modifiers
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
Principal Investigator
Kenichi Sugihara, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Tokyo Medical and Dental University
Authority:
United States: Federal Government
Study ID:
CDR0000512573
NCT ID:
NCT00392899
Start Date:
October 2006
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage II colon cancer
- stage II rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Colonic Neoplasms
- Colorectal Neoplasms
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