Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Tokyo Medical and Dental University
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00660894
First received: April 16, 2008
Last updated: October 28, 2010
Last verified: January 2010
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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: leucovorin calcium Drug: tegafur-gimeracil-oteracil potassium Drug: tegafur-uracil Genetic: gene expression analysis Other: laboratory biomarker analysis Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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: | 1480 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin calcium after curative surgery .
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 | |
| Tokyo, Japan, 113-8519 | |
Sponsors and Collaborators
Tokyo Medical and Dental University
Investigators
| Principal Investigator: | Kenichi Sugihara, MD, PhD | Tokyo Medical and Dental University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00660894 History of Changes |
| Other Study ID Numbers: | CDR0000593164, TMDU-TRICC0706 |
| Study First Received: | April 16, 2008 |
| Last Updated: | October 28, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the colon stage III colon cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic Tegafur S 1 (combination) |
Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 23, 2013