Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
This trial is active, not recruiting.
|Treatments||folinate calcium, tegafur-uracil, tegafur-gimeracil-oteracil potassium|
|Sponsor||Translational Research Informatics Center, Kobe, Hyogo, Japan|
|Start date||April 2008|
|End date||June 2012|
|Trial size||1535 participants|
|Trial identifier||NCT00660894, CDR0000593164, TMDU-TRICC0706|
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 dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer.
PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Identification of predictive markers
Male or female participants from 20 years up to 80 years old.
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
|Official title||Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression|
|Principal investigator||Kenichi Sugihara, MD, PhD|
|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 1 of 2 treatment arms. - Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. The treatment repeats 5 times every 5 weeks. - Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4 times every 6 weeks. Biological samples are collected for gene expression analysis for identification of predictive markers.|
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