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

Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)
Overall Status
Completed
CT.gov ID
NCT00660894
Collaborator
(none)
1,535
Enrollment
1
Location
2
Arms
87
Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1535 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: tegafur-gimeracil-oteracil potassium

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.

Drug: tegafur-gimeracil-oteracil potassium
Other Names:
  • S-1, TS-1

    		•
    Active Comparator: tegafur-uracil and folinate calcium

    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.

    Drug: folinate calcium
    Other Names:
  • Leucovorin, leucovorin

    • Drug: tegafur-uracil
    Other Names:
  • UFT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival []

    Secondary Outcome Measures

    1. Overall survival []

    2. Adverse event []

    3. Pharmaco-economics []

    4. Identification of predictive markers []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tokyo Medical and Dental University Tokyo Japan 113-8519

    Sponsors and Collaborators

    • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    Investigators

    • Principal Investigator: Kenichi Sugihara, MD, PhD, Tokyo Medical and Dental University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
    ClinicalTrials.gov Identifier:
    NCT00660894
    Other Study ID Numbers:
    • CDR0000593164
    • TMDU-TRICC0706
    First Posted:
    Apr 17, 2008
    Last Update Posted:
    Aug 3, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
    adenocarcinoma of the colon
    stage III colon cancer
    Additional relevant MeSH terms:
    Colonic Neoplasms
    Leucovorin
    Tegafur
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of Aug 3, 2016