Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392899
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2006-10-25
Brief Title:
Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Sponsor:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Organization:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Study Overview
Official Title:
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs Observation in Curatively Resected Stage II Colon Cancer
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer
Secondary
Compare relapse-free and overall survival of patients treated with these regimens
Compare the occurrence of adverse events in patients treated with these regimens
OUTLINE This is a randomized controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo observation
Arm II Patients receive oral tegafur-uracil on days 1-5 Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 2000 patients will be accrued for this study
Primary
Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer
Secondary
Compare relapse-free and overall survival of patients treated with these regimens
Compare the occurrence of adverse events in patients treated with these regimens
OUTLINE This is a randomized controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo observation
Arm II Patients receive oral tegafur-uracil on days 1-5 Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 2000 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TMDU-BRI-CC-05-01 | None | None | None |