Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003835
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Stage III Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Intergroup Trial of Irinotecan CPT-11 NSC 616348 Plus FluorouracilLeucovorin 5-FULV Versus FluorouracilLeucovorin Alone After Curative Resection for Patients With Stage III Colon Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which chemotherapy regimen is more effective for stage III colon cancer Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer
Detailed Description:
PRIMARY OBJECTIVES
I Compare the overall and disease free survival of patients with stage III colon cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan
II Assess prognostic markers and correlate their expression with disease free and overall survival of these patients
III Assess the influence of diet body mass index and physical activity on the risk of cancer recurrence and survival in these patients
IV Assess the influence of diet obesity and physical activity on the risk of toxicity associated with adjuvant therapy in these patients
V Determine whether pathological features including tumor grade tumor mitotic proliferation index tumor border configuration and host lymphoid response to tumor and lymphatic vessel venous vessel and perineural invasion predict outcome in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to lymph node involvement 1-3 vs 4 or more histology poorly differentiated or undifferentiated vs well or moderately differentiated and preoperative serum CEA less than 50 ngmL vs at least 50 ngmL vs unknown Study therapy must begin within 21-56 days after surgery Patients are randomized to one of two treatment arms
ARM I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks Treatment is repeated every 8 weeks for 4 courses
ARM II Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV then followed by fluorouracil IV weekly for 4 weeks Treatment is repeated every 6 weeks for 5 courses
Patients complete a food questionnaire at the beginning of the third course and then at 6 months after study therapy
Patients are followed every 3 months for 2 years every 4 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 1260 patients will be accrued for this study within 3 years
I Compare the overall and disease free survival of patients with stage III colon cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan
II Assess prognostic markers and correlate their expression with disease free and overall survival of these patients
III Assess the influence of diet body mass index and physical activity on the risk of cancer recurrence and survival in these patients
IV Assess the influence of diet obesity and physical activity on the risk of toxicity associated with adjuvant therapy in these patients
V Determine whether pathological features including tumor grade tumor mitotic proliferation index tumor border configuration and host lymphoid response to tumor and lymphatic vessel venous vessel and perineural invasion predict outcome in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to lymph node involvement 1-3 vs 4 or more histology poorly differentiated or undifferentiated vs well or moderately differentiated and preoperative serum CEA less than 50 ngmL vs at least 50 ngmL vs unknown Study therapy must begin within 21-56 days after surgery Patients are randomized to one of two treatment arms
ARM I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks Treatment is repeated every 8 weeks for 4 courses
ARM II Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV then followed by fluorouracil IV weekly for 4 weeks Treatment is repeated every 6 weeks for 5 courses
Patients complete a food questionnaire at the beginning of the third course and then at 6 months after study therapy
Patients are followed every 3 months for 2 years every 4 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 1260 patients will be accrued for this study within 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 |
|---|---|---|---|
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |
| NCI-2012-01844 | REGISTRY | None | None |
| SWOG-C89803 | None | None | None |
| NCCTG-C89803 | None | None | None |
| CDR0000066992 | None | None | None |
| CAN-NCIC-CO15 | None | None | None |
| E-89803 | None | None | None |
| CALGB 89803 | OTHER | None | None |
| C89803 | OTHER | None | None |