Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006479
Status:
UNKNOWN
Last Update Posted:
2011-04-18
First Post:
2000-11-06
Brief Title:
Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FULV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study
Status:
UNKNOWN
Status Verified Date:
2000-12
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 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 combining chemotherapy with surgery may kill more tumor cells It is not yet known if surgery is more effective with or without chemotherapy for liver metastases
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Compare the progression-free and overall survival of patients with resectable colorectal liver metastases treated with surgery with or without neoadjuvant and adjuvant oxaliplatin fluorouracil and leucovorin calcium
Compare the percentage of patients with total resection with these two treatments
OUTLINE This is a multicenter study Patients are stratified according to participating center prior adjuvant chemotherapy yes vs no plasma CEA level in ngmL at diagnosis of liver metastases 5 or less vs 6 to 30 vs 31 or greater serosa extension of primary cancer absent T1 or T2 vs present T3 or T4 lymphatic spread of primary cancer absent vs present N time interval between diagnosis of primary tumor to metastases 2 years or more vs fewer than 2 years and number of metastases 1 to 3 vs 4 Patients are randomized to one of two treatment arms
Arm I Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium LV IV over 2 hours followed by fluorouracil 5-FU IV over 22 hours on days 1 and 2 Treatment repeats every 15 days for 6 courses in the absence of disease progression or unacceptable toxicity
At 2 to 5 weeks after chemotherapy patients undergo liver resection Patients with progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks after completion of course 3 and do not receive postoperative chemotherapy
At 2 to 5 weeks after surgery patients receive oxaliplatin LV and 5-FU as in preoperative chemotherapy
Arm II Patients undergo liver resection Patients are followed every 3 months for 2 years and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 330 patients 165 per arm will be accrued for this study within 3 years
Compare the progression-free and overall survival of patients with resectable colorectal liver metastases treated with surgery with or without neoadjuvant and adjuvant oxaliplatin fluorouracil and leucovorin calcium
Compare the percentage of patients with total resection with these two treatments
OUTLINE This is a multicenter study Patients are stratified according to participating center prior adjuvant chemotherapy yes vs no plasma CEA level in ngmL at diagnosis of liver metastases 5 or less vs 6 to 30 vs 31 or greater serosa extension of primary cancer absent T1 or T2 vs present T3 or T4 lymphatic spread of primary cancer absent vs present N time interval between diagnosis of primary tumor to metastases 2 years or more vs fewer than 2 years and number of metastases 1 to 3 vs 4 Patients are randomized to one of two treatment arms
Arm I Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium LV IV over 2 hours followed by fluorouracil 5-FU IV over 22 hours on days 1 and 2 Treatment repeats every 15 days for 6 courses in the absence of disease progression or unacceptable toxicity
At 2 to 5 weeks after chemotherapy patients undergo liver resection Patients with progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks after completion of course 3 and do not receive postoperative chemotherapy
At 2 to 5 weeks after surgery patients receive oxaliplatin LV and 5-FU as in preoperative chemotherapy
Arm II Patients undergo liver resection Patients are followed every 3 months for 2 years and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 330 patients 165 per arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-40983 | None | None | None |
| AGITG-EORTC-40983 | None | None | None |
| ALM-CAO-EORTC-40983 | None | None | None |
| CRUK-LON-EORTC-40983 | None | None | None |
| FFCD-EORTC-40983 | None | None | None |
| EU-20048 | None | None | None |
| CRC-EORTC-40983 | None | None | None |