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

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

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: folinate calcium; Drug: tegafur-gimeracil-oteracil potassium; Drug: tegafur-uracil

Study type: Interventional

Funder types: Other

Identifiers

NCT00660894

TMDU-TRICC0706 (Other Identifier)

CDR0000593164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,535 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,535 participants in 2 patient groups

tegafur-gimeracil-oteracil potassium

Experimental group

Description:

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.

Treatment:

Drug: tegafur-gimeracil-oteracil potassium

tegafur-uracil and folinate calcium

Active Comparator group

Description:

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.

Treatment:

Drug: tegafur-uracil

Drug: folinate calcium