Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Tokyo Medical and Dental University |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00392899 |
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: tegafur-uracil Procedure: adjuvant therapy Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer |
Estimated Enrollment: | 2000 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectosigmoid
PATIENT CHARACTERISTICS:
None of the following conditions:
PRIOR CONCURRENT THERAPY:
Study Chair: | Kenichi Sugihara, MD | Tokyo Medical and Dental University |
Study ID Numbers: | CDR0000512573, TMDU-BRI-CC-05-01 |
Study First Received: | October 25, 2006 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00392899 |
Health Authority: | Unspecified |
stage II colon cancer stage II rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Digestive System Neoplasms Tegafur Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |