Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660894
• Other study ID #: CDR0000593164
• Secondary ID: TMDU-TRICC0706
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2008
• Last updated: August 2, 2016
• Start date: April 2008
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board, Tokyo Medical and Dental University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: July 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• folinate calcium

• tegafur-uracil

• tegafur-gimeracil-oteracil potassium

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival			No
Secondary	Overall survival			No
Secondary	Adverse event			Yes
Secondary	Pharmaco-economics			No
Secondary	Identification of predictive markers			No