Colorectal Cancer
Conditions
Keywords
stage II colon cancer, stage II rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Brief summary
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer. PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.
Detailed description
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.
Interventions
UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
Sponsors
Tokyo Medical and Dental University
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 9 years | Disease-free survival is defined as the time from date of enrollement until date of recurrence, other malignancies or death from any cause, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 9 years | Overall survival is defined as time from date of enrollment until date of death from any cause. |
| Types and severities of adverse events | 15 months | Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center. |
Countries
Japan
Outcome results
None listed