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

NCT ID: NCT00660894

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1535 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2015-07-31

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

tegafur-gimeracil-oteracil potassium

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

folinate calcium

Intervention Type: DRUG

tegafur-uracil

Intervention Type: DRUG

Interventions

folinate calcium

Intervention Type: DRUG

tegafur-uracil

Intervention Type: DRUG

tegafur-gimeracil-oteracil potassium

Intervention Type: DRUG

Other Intervention Names

Leucovorin, leucovorin; UFT; S-1, TS-1

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenichi Sugihara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical and Dental University

Locations

Tokyo Medical and Dental University

Tokyo, Tokyo, Japan

Countries

Japan

References

Kusumoto T, Ishiguro M, Nakatani E, Yoshida M, Inoue T, Nakamoto Y, Shiomi A, Takagane A, Sunami E, Shinozaki H, Takii Y, Maeda A, Ojima H, Hashida H, Mukaiya M, Yokoyama T, Nakamura M, Munemoto Y, Sugihara K. Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer. ESMO Open. 2018 Oct 7;3(6):e000428. doi: 10.1136/esmoopen-2018-000428. eCollection 2018.

Reference Type: DERIVED

PMID: 30425843 (View on PubMed)

Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, Nakamoto Y, Kinugasa Y, Takagane A, Endo T, Shinozaki H, Takii Y, Mochizuki H, Kotake K, Kameoka S, Takahashi K, Watanabe T, Watanabe M, Boku N, Tomita N, Nakatani E, Sugihara K; ACTS-CC study group. S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial). Ann Oncol. 2014 Sep;25(9):1743-1749. doi: 10.1093/annonc/mdu232. Epub 2014 Jun 18.

Reference Type: DERIVED

PMID: 24942277 (View on PubMed)

Other Identifiers

TMDU-TRICC0706

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000593164

Identifier Type: -

Identifier Source: org_study_id