Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002551
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
1999-11-01
Brief Title:
SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Postoperative Evaluation of 5-FU by Bolus Injection vs 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT vs Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT Plus Bolus 5-FU Plus Leucovorin in Patients With Rectal Cancer Phase III
Status:
COMPLETED
Status Verified Date:
2013-04
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known which treatment regimen is more effective for rectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed
Detailed Description:
OBJECTIVES I Compare the overall and relapse free survival of patients with stage II or III rectal cancer treated with one of the following three regimens bolus injections of fluorouracil 5-FU prior to and following pelvic irradiation plus protracted venous infusion PVI 5-FU radiosensitization vs PVI 5-FU prior to and following pelvic irradiation plus PVI 5-FU radiosensitization vs bolus 5-FU with leucovorin calcium and levamisole prior to and following pelvic irradiation II Describe relapse patterns and tolerance associated with these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to type of prior surgery abdominoperineal resection vs anterior resection nodal status N0 vs N1 vs N2-3 depth of tumor invasion T1-2 vs T3 vs T4a vs T4b time from surgery to study entry 20-45 days vs 46-70 days participating center and performance status 0-1 vs 2 Patients are randomized to one of three treatment arms Arm I Patients receive fluorouracil 5-FU IV on days 1-5 and 29-33 5-FU is then given as a continuous infusion beginning on day 57 and continuing concurrently with radiotherapy for 5 weeks Following a 28 day break from treatment patients receive 5-FU IV on days 1-5 of a 28 day course Postradiotherapy treatment repeats for a total of 2 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive 5-FU IV continuously on days 1-42 5-FU and radiotherapy are then administered as in arm II Arm III Patients receive leucovorin calcium CF IV followed by 5-FU IV on days 1-5 and 29-33 Patients also receive oral levamisole twice daily on days 1-3 15-17 29-31 and 43-45 CF IV and 5-FU IV are then given on days 57-60 and 85-88 concurrently with radiotherapy Following a 28 day break from treatment patients receive CF IV and 5-FU IV on days 1-5 and 29-33 and oral levamisole twice daily on days 1-3 15-17 29-31 and 43-45 in the absence of disease progression or unacceptable toxicity All patients receive radiotherapy 5 days per week for 5 weeks starting on day 57 Patients are followed every 4 months for 2 years then every 6 months for 4 years and then annually until death
PROJECTED ACCRUAL A total of 1800 patients 600 per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to type of prior surgery abdominoperineal resection vs anterior resection nodal status N0 vs N1 vs N2-3 depth of tumor invasion T1-2 vs T3 vs T4a vs T4b time from surgery to study entry 20-45 days vs 46-70 days participating center and performance status 0-1 vs 2 Patients are randomized to one of three treatment arms Arm I Patients receive fluorouracil 5-FU IV on days 1-5 and 29-33 5-FU is then given as a continuous infusion beginning on day 57 and continuing concurrently with radiotherapy for 5 weeks Following a 28 day break from treatment patients receive 5-FU IV on days 1-5 of a 28 day course Postradiotherapy treatment repeats for a total of 2 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive 5-FU IV continuously on days 1-42 5-FU and radiotherapy are then administered as in arm II Arm III Patients receive leucovorin calcium CF IV followed by 5-FU IV on days 1-5 and 29-33 Patients also receive oral levamisole twice daily on days 1-3 15-17 29-31 and 43-45 CF IV and 5-FU IV are then given on days 57-60 and 85-88 concurrently with radiotherapy Following a 28 day break from treatment patients receive CF IV and 5-FU IV on days 1-5 and 29-33 and oral levamisole twice daily on days 1-3 15-17 29-31 and 43-45 in the absence of disease progression or unacceptable toxicity All patients receive radiotherapy 5 days per week for 5 weeks starting on day 57 Patients are followed every 4 months for 2 years then every 6 months for 4 years and then annually until death
PROJECTED ACCRUAL A total of 1800 patients 600 per arm 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 |
|---|---|---|---|
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-9304 | OTHER | None | None |
| CAN-NCIC-CO11 | OTHER | None | None |
| NCCTG-934751 | OTHER | None | None |
| RTOG-9403 | OTHER | None | None |
| CLB-C9491 | OTHER | None | None |
| INT-0144 | OTHER | None | None |