Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002893
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Palliative chemotherapy may help patients with advanced colorectal cancer live longer and more comfortably
PURPOSE Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES I Compare the survival and quality of life of patients with metastatic or recurrent colorectal cancer receiving palliative therapy with leucovorinfluorouracil vs continuous-infusion fluorouracil vs ICI D1694 II Compare the survival and quality of life of patients with stable or responding disease after 12 weeks of initial treatment randomized to receive 12 additional weeks of chemotherapy vs no further treatment
OUTLINE This is a randomized study Patients are stratified by participating institution Patients are randomized to one of three treatment regimens The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses The second group receives continuous-infusion fluorouracil for 12 weeks The third group receive ICI D1694 every 21 days for a total of 4 courses Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy until evidence of disease progression Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 900 patients will be entered
OUTLINE This is a randomized study Patients are stratified by participating institution Patients are randomized to one of three treatment regimens The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses The second group receives continuous-infusion fluorouracil for 12 weeks The third group receive ICI D1694 every 21 days for a total of 4 courses Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy until evidence of disease progression Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 900 patients will be entered
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 |
|---|---|---|---|
| EU-96049 | None | None | None |
| MRC-CR06 | None | None | None |