Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: UFT adjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UFT adjuvant therapy group<br>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. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed. | Drug: UFT adjuvant chemotherapy<br>* 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.<br>* Other names: Adjuvant chemotherapy with tegafur-uracil;|
| No Intervention: Observation group<br>Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | 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. | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival is defined as time from date of enrollment until date of death from any cause. | 9 years | 
| Types and severities of adverse events | 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. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II colon cancer, stage II rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum