Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.

Secondary

1. Compare relapse-free and overall survival of patients treated with these regimens.
2. Compare the occurrence of adverse events in patients treated with these regimens.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior chemotherapy
• No prior or concurrent radiotherapy
• No concurrent prophylactic growth factors
• No concurrent biologic response modifiers

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

Expected Enrollment

A total of 2,000 patients will be accrued for this study.

Outcomes

Disease-free survival

Relapse-free survival
Overall survival
Adverse events

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.

Trial Contact Information

Trial Lead Organizations

Tokyo Medical and Dental University

Kenichi Sugihara, MD, PhD, Protocol chair		Ph: 81-3-5803-5261 Email: k-sugi.srg2@tmd.ac.jp

Registry Information
Official Title		Randomized Phase III Trial of Adjuvant Chemotherapy with UFT vs. Observation in Curatively Resected Stage II Colon Cancer
Trial Start Date		2006-10-02
Trial Completion Date		2014-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00392899
Date Submitted to PDQ		2006-10-02
Information Last Verified		2009-07-05

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