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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660894
First Posted: April 17, 2008
Last Update Posted: August 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
  Purpose

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 Intervention Phase
Colorectal Cancer Drug: folinate calcium Drug: tegafur-uracil Drug: tegafur-gimeracil-oteracil potassium Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Disease-free survival

Secondary Outcome Measures:
  • Overall survival
  • Adverse event
  • Pharmaco-economics
  • Identification of predictive markers

Enrollment: 1535
Study Start Date: April 2008
Study Completion Date: July 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Leucovorin, leucovorin
Drug: tegafur-uracil
Other Name: UFT

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660894


Locations
Japan
Tokyo Medical and Dental University
Tokyo, Japan, 113-8519
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Investigators
Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00660894     History of Changes
Other Study ID Numbers: CDR0000593164
TMDU-TRICC0706 ( Other Identifier: National Cancer Institute )
First Submitted: April 16, 2008
First Posted: April 17, 2008
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
adenocarcinoma of the colon
stage III colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Tegafur
Levoleucovorin
Leucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances