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

April 16, 2008
July 14, 2014
April 2008
June 2012   (final data collection date for primary outcome measure)
Disease-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00660894 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: folinate calcium
    Other Name: Leucovorin, leucovorin
  • Drug: tegafur-uracil
    Other Name: UFT
  • Drug: tegafur-gimeracil-oteracil potassium
    Other Name: S-1, TS-1
  • 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.
    Intervention: Drug: tegafur-gimeracil-oteracil potassium
  • 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.
    Interventions:
    • Drug: folinate calcium
    • Drug: tegafur-uracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1535
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00660894
CDR0000593164, TMDU-TRICC0706
No
Translational Research Informatics Center, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
Not Provided
Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University
Translational Research Informatics Center, Kobe, Hyogo, Japan
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP