Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002525
Status:
TERMINATED
Last Update Posted:
2023-06-28
First Post:
1999-11-01
Brief Title:
Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Intergroup Prospectively Randomized Trial of Perioperative 5-FU After Curative Resection Followed by 5-FULeucovorin for Patients With Colon Cancer
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped before reaching its accrual goal due to slow accrual
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 Combining more than one drug and giving drugs in different ways may kill more tumor cells It is not yet known if surgery is more effective with or without chemotherapy for colon cancer
PURPOSE Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil 5-FU chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Dukes B3 or C colon cancer
PURPOSE Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil 5-FU chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Dukes B3 or C colon cancer
Detailed Description:
OBJECTIVES
I To determine if adjuvant therapy with one week of continuous 5-FU given within 24 hours of a curative colon resection followed by 6 months of 5-FUleucovorin is effective in prolonging the disease-free survival and increasing overall survival in patients with Dukes B3 or C colon cancer when compared to patients who are treated with 5-FUleucovorin only
II 1 To determine if a week of perioperative continuous 5-FU affects disease-free survival and overall survival in patients with Dukes B2 colon cancer
OUTLINE This is an open-label randomized phase III study Patients undergo curative colon resection via laparotomy Patients are randomized to 1 of 2 arms in a 11 ratio
Arm I Perioperative 5-FU Within 24 hours of the colon resection patients receive perioperative 5-fluorouracil 5-FU intravenously IV over 24 hours for 7 days
Arm II No perioperative 5-FU Patients receive no perioperative fluorouracil
After surgery patients with stage I stage IIA or stage IV colon cancer are immediately removed from study Patients with stage IIB IIC or III colon cancer are re-registered within 35 days postoperatively Beginning 21-35 days after surgery patients with stage IIC or III disease receive leucovorin calcium IV bolus immediately followed by 5-FU IV bolus on days 1-5 Courses repeat every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients with stage IIB disease do not receive adjuvant 5-FU and leucovorin calcium
Patients are followed every 3 months for 2 years then every 6 months for 2 years and then annually until 15 years
PROJECTED ACCRUAL A total of 800-2000 patients at least 400 per treatment arm will be accrued for this study over 2-3 years
I To determine if adjuvant therapy with one week of continuous 5-FU given within 24 hours of a curative colon resection followed by 6 months of 5-FUleucovorin is effective in prolonging the disease-free survival and increasing overall survival in patients with Dukes B3 or C colon cancer when compared to patients who are treated with 5-FUleucovorin only
II 1 To determine if a week of perioperative continuous 5-FU affects disease-free survival and overall survival in patients with Dukes B2 colon cancer
OUTLINE This is an open-label randomized phase III study Patients undergo curative colon resection via laparotomy Patients are randomized to 1 of 2 arms in a 11 ratio
Arm I Perioperative 5-FU Within 24 hours of the colon resection patients receive perioperative 5-fluorouracil 5-FU intravenously IV over 24 hours for 7 days
Arm II No perioperative 5-FU Patients receive no perioperative fluorouracil
After surgery patients with stage I stage IIA or stage IV colon cancer are immediately removed from study Patients with stage IIB IIC or III colon cancer are re-registered within 35 days postoperatively Beginning 21-35 days after surgery patients with stage IIC or III disease receive leucovorin calcium IV bolus immediately followed by 5-FU IV bolus on days 1-5 Courses repeat every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients with stage IIB disease do not receive adjuvant 5-FU and leucovorin calcium
Patients are followed every 3 months for 2 years then every 6 months for 2 years and then annually until 15 years
PROJECTED ACCRUAL A total of 800-2000 patients at least 400 per treatment arm will be accrued for this study over 2-3 years
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 |
|---|---|---|---|
| E1292 | OTHER | None | None |
| U10CA023318 | NIH | None | None |
| CDR0000078337 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA023318 |