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

Sponsored by:	Tokyo Medical and Dental University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00660894

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: S-1 Drug: leucovorin calcium Drug: tegafur-uracil Procedure: adjuvant therapy Procedure: gene expression analysis Procedure: laboratory biomarker analysis	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Calcium gluconate Tegafur Uracil S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	1240
Study Start Date:	April 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the efficacy of S-1 vs tegafur-uracil and leucovorin calcium after curative surgery in patients with stage III colon cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral tegafur-uracil and oral leucovorin calcium 3 times daily on days 1-21. Treatment repeats every 5 weeks for up to 5 courses.
Arm II: Patients receive oral S-1 twice daily on days 1-28. Treatment repeats every 6 weeks for up to 4 courses.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660894

Locations

Japan
Tokyo Medical and Dental University	Recruiting
Tokyo, Japan, 113-8519
Contact: Kenichi Sugihara, MD 81-3-5803-5261 k-sugi.srg2@tmd.ac.jp

Sponsors and Collaborators

Tokyo Medical and Dental University

Investigators

Principal Investigator:

Kenichi Sugihara, MD

Tokyo Medical and Dental University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000593164, TMDU-TRICC0706
Study First Received:	April 16, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00660894
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon
stage III colon cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Tegafur
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Calcium, Dietary
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 15, 2009