Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003287
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
First Line Infusional 5-Fluorouracil Folinic Acid and Oxaliplatin for Metastatic Colorectal Cancer or Loco-Regional Recurrency - Role of Chronomodulated Delivery Upon Survival - A Multicenter Randomized Phase III Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 Combining more than one drug may kill more tumor cells It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer
PURPOSE Randomized phase III trial to study the effectiveness of combining fluorouracil leucovorin and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer
PURPOSE Randomized phase III trial to study the effectiveness of combining fluorouracil leucovorin and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the effects of chronomodulated versus nonchronomodulated infusional administration of a 3 drug high-dose chemotherapy regimen on survival in patients with locoregionally recurrent or metastatic colorectal cancer II Assess the antitumor effect of the combination of fluorouracil leucovorin calcium and oxaliplatin given as first line chemotherapy in these patients III Assess the response rate and toxicity of this treatment in these patients IV Assess the quality of life of patients receiving this treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status ECOG 0-1 vs 2 extent of liver involvement none vs less than 25 vs 25 or greater and institution Patients are randomized into 2 arms Arm I chronotherapy Patients receive a 4 day infusion of fluorouracil leucovorin calcium and oxaliplatin administered via pump using chronomodulated delivery rates Arm II fixed infusion rate Patients receive leucovorin calcium and oxaliplatin as 2 hour concurrent infusions followed by fluorouracil as a 22 hour infusion on day 1 On day 2 patients receive a 2 hour infusion of leucovorin calcium followed by a 22 hour infusion of fluorouracil For patients on both arms courses repeat every 2 weeks until the occurrence of disease progression severe toxicity or complete remission for a minimum of 4 months Quality of life is assessed prior to treatment and 2 weeks after courses 4 and 8 Patients are followed for survival
PROJECTED ACCRUAL A total of 554 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status ECOG 0-1 vs 2 extent of liver involvement none vs less than 25 vs 25 or greater and institution Patients are randomized into 2 arms Arm I chronotherapy Patients receive a 4 day infusion of fluorouracil leucovorin calcium and oxaliplatin administered via pump using chronomodulated delivery rates Arm II fixed infusion rate Patients receive leucovorin calcium and oxaliplatin as 2 hour concurrent infusions followed by fluorouracil as a 22 hour infusion on day 1 On day 2 patients receive a 2 hour infusion of leucovorin calcium followed by a 22 hour infusion of fluorouracil For patients on both arms courses repeat every 2 weeks until the occurrence of disease progression severe toxicity or complete remission for a minimum of 4 months Quality of life is assessed prior to treatment and 2 weeks after courses 4 and 8 Patients are followed for survival
PROJECTED ACCRUAL A total of 554 patients 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 |
|---|---|---|---|
| EORTC-05963 | None | None | None |