Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043004
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2002-08-05
Brief Title:
Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With 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:
CLOCC Trial Chemotherapy Local Ablation Versus Chemotherapy Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low 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 Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread by blocking blood flow Others find tumor cells and help kill them or carry tumor-killing substances to them Radiofrequency ablation uses high-frequency electric current to kill tumor cells It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases
PURPOSE This randomized phase II trial is studying combination chemotherapy bevacizumab and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer
PURPOSE This randomized phase II trial is studying combination chemotherapy bevacizumab and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare the 30-month overall survival rate of patients with unresectable liver metastases secondary to colorectal adenocarcinoma treated with chemotherapy and bevacizumab with or without radiofrequency interstitial ablation
Secondary
Compare overall survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Determine the health economics associated with this study
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to treatment center prior adjuvant chemotherapy for primary cancer yes vs no prior chemotherapy for liver metastases yes vs no and route of randomization before surgery vs during surgery Patients are randomized to 1 of 2 treatment arms
Arm I Within 4 weeks of randomization patients undergo radiofrequency interstitial ablation RFA with or without additional resection of resectable lesions Within 8 weeks after RFA patients receive chemotherapy and bevacizumab
Arm II Within 4 weeks of randomization patients receive chemotherapy and bevacizumab
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients in both arms receive one of the following chemotherapy and bevacizumab regimens to be determined by participating center
Regimen A Patients receive oxaliplatin IV over 2 hours on day 1 of weeks 1 3 and 5 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours on day 1 of weeks 1-6 and bevacizumab IV over 30-90 minutes on days 1 or 2 15 or 16 and 29 or 30 Treatment repeats every 7 weeks for 4 courses
Regimen B Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours and bevacizumab IV over 30-90 minutes on day 1 or 3 Treatment repeats every 15 days for 12 courses
Regimen C Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2 and bevacizumab IV over 30-90 minutes on day 1 or 3 Treatment repeats every 15 days for 12 courses
Quality of life is assessed at baseline within 1 week after completion of RFA arm I only within 1 week before start of chemotherapy arm I only at weeks 6 12 18 and 24 during chemotherapy every 3 months for 2 years after treatment and then every 6 months thereafter
After completion of study treatment patients are followed every 3 months for 2½ years and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 152 patients 71 per treatment arm will be accrued for this study within 3 years
Primary
Compare the 30-month overall survival rate of patients with unresectable liver metastases secondary to colorectal adenocarcinoma treated with chemotherapy and bevacizumab with or without radiofrequency interstitial ablation
Secondary
Compare overall survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Determine the health economics associated with this study
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to treatment center prior adjuvant chemotherapy for primary cancer yes vs no prior chemotherapy for liver metastases yes vs no and route of randomization before surgery vs during surgery Patients are randomized to 1 of 2 treatment arms
Arm I Within 4 weeks of randomization patients undergo radiofrequency interstitial ablation RFA with or without additional resection of resectable lesions Within 8 weeks after RFA patients receive chemotherapy and bevacizumab
Arm II Within 4 weeks of randomization patients receive chemotherapy and bevacizumab
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients in both arms receive one of the following chemotherapy and bevacizumab regimens to be determined by participating center
Regimen A Patients receive oxaliplatin IV over 2 hours on day 1 of weeks 1 3 and 5 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours on day 1 of weeks 1-6 and bevacizumab IV over 30-90 minutes on days 1 or 2 15 or 16 and 29 or 30 Treatment repeats every 7 weeks for 4 courses
Regimen B Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours and bevacizumab IV over 30-90 minutes on day 1 or 3 Treatment repeats every 15 days for 12 courses
Regimen C Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2 and bevacizumab IV over 30-90 minutes on day 1 or 3 Treatment repeats every 15 days for 12 courses
Quality of life is assessed at baseline within 1 week after completion of RFA arm I only within 1 week before start of chemotherapy arm I only at weeks 6 12 18 and 24 during chemotherapy every 3 months for 2 years after treatment and then every 6 months thereafter
After completion of study treatment patients are followed every 3 months for 2½ years and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 152 patients 71 per treatment arm 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 |
|---|---|---|---|
| NCRI-EORTC-40004 | None | None | None |
| EORTC-40004 | None | None | None |
| ALM-CAO-EORTC-40004 | None | None | None |