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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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
folinate calcium
tegafur-uracil
tegafur-gimeracil-oteracil potassium
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, stage III colon cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokyo Medical and Dental University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tegafur-gimeracil-oteracil potassium

tegafur-uracil and folinate calcium

Arm 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.

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.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Overall survival
Adverse event
Pharmaco-economics
Identification of predictive markers

Full Information

First Posted
April 16, 2008
Last Updated
August 2, 2016
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00660894
Brief Title
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the colon, stage III colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tegafur-gimeracil-oteracil potassium
Arm Type
Experimental
Arm 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.
Arm Title
tegafur-uracil and folinate calcium
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
folinate calcium
Other Intervention Name(s)
Leucovorin, leucovorin
Intervention Type
Drug
Intervention Name(s)
tegafur-uracil
Other Intervention Name(s)
UFT
Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Other Intervention Name(s)
S-1, TS-1
Primary Outcome Measure Information:
Title
Disease-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Adverse event
Title
Pharmaco-economics
Title
Identification of predictive markers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenichi Sugihara, MD, PhD
Organizational Affiliation
Tokyo Medical and Dental University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokyo Medical and Dental University
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30425843
Citation
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.
Results Reference
derived
PubMed Identifier
24942277
Citation
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.
Results Reference
derived

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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

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