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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00660894
First received: April 16, 2008
Last updated: July 14, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Adverse event [ Designated as safety issue: Yes ]
  • Pharmaco-economics [ Designated as safety issue: No ]
  • Identification of predictive markers [ Designated as safety issue: No ]

Enrollment: 1535
Study Start Date: April 2008
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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided by Translational Research Informatics Center, Kobe, Hyogo, Japan

Additional 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
Study First Received: April 16, 2008
Last Updated: July 14, 2014
Health Authority: Japan: Institutional Review Board, Tokyo Medical and Dental University

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

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

ClinicalTrials.gov processed this record on October 19, 2014