Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments folinate calcium, tegafur-uracil, tegafur-gimeracil-oteracil potassium
Phase phase 3
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive tegafur-gimeracil-oteracil potassium(S-1) orally twice daily for 28 days with a subsequent pause of 14 days. This repeats 4 times every 6 weeks.
tegafur-gimeracil-oteracil potassium S-1, TS-1
(Active Comparator)
Patients receive tegafur-uracil(UFT) plus folinate calcium(leucovorin) orally every 8 hours for 21 days with a subsequent pause of 7 days. This repeats 5 times every 5 weeks.
folinate calcium Leucovorin, leucovorin
tegafur-uracil UFT

Primary Outcomes

Measure
Disease-free survival
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:
Adverse event
time frame:
Pharmaco-economics
time frame:
Identification of predictive markers
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.