Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510627
Status:
WITHDRAWN
Last Update Posted:
2017-03-03
First Post:
2007-07-31
Brief Title:
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Prospective Randomized Active-Control Multi-Center Study Assessing Overall Survival Using Chemotherapy With or Without Impedance-Based Radiofrequency Ablation for Subjects With Colorectal Cancer and Incurable Metastatic Liver Disease Failing at Least First-Line Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Boston Scientific has decided to close the Study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Prometheus
Brief Summary:
The purpose of this study is to determine whether patients treated with Radiofrequency Ablation RFA in conjunction with chemotherapy have a better overall survival rate than patients treated with chemotherapy alone
Detailed Description:
The American Cancer Society has estimated that colorectal cancer is the second leading cause of cancer related deaths with 106370 new cases diagnosed in 2004 Due to the unique nature of the hepatic circulatory system with preferential portal venous drainage of the gastrointestinal tract the liver is the most common site for metastatic tumor growth from a colorectal carcinoma It is estimated that approximately 20 of patients diagnosed with colorectal cancer will present with liver involvement at the time of diagnosis and 50 of patients will manifest metastatic involvement of the liver following resection of the primary colorectal cancer Over one half of patients who die of colorectal cancer have liver metastases at autopsy
The current gold standard in the treatment of isolated metastatic liver disease is curative hepatic resection Only within the last 20 years has surgical resection become a viable option as in the past it was considered unjustified due to high morbidity and mortality rates The primary drawback to hepatic resection is the sheer number of patients for whom it is contraindicated Only 10-20 of patients liver metastases are candidates for surgical resection owing to factors such as tumor locations size extent of disease and other medical co-morbidities
Historically in cases where hepatic resection was contraindicated systemic chemotherapy was the only alternative treatment In the last several years an increasing number of hepatic directed therapies have become available such as hepatic artery ligation radiation hepatic artery infusion of chemotherapy chemoembolization and mechanical ablation of the tumors
One mechanical method of ablation involves the use of radiofrequency thermal technology also called radiofrequency ablation RFA The RFA procedure involves inserting an RF electrode into the center of a hepatic tumor mass under ultrasonic or CT guidance Radiofrequency energy is then applied through the electrode causing a thermal injury to the surrounding tumor tissue Currently there are two basic designs for monitoring inter-procedural progress during RFA temperature monitoring of set points within the target tissue with thermocouples or assessing the system-wide impedance of tissue adjacent to the deployed electrode tines Radiofrequency ablation systems are comprised of three components a radiofrequency generator an active electrode and dispersive electrodes
To date no prospective multi-center trials have been completed which would conclusively demonstrate whether RFA is an effective adjunct to systemic chemotherapy with respect to advantages in median overall survival compared with chemotherapy alone The primary objective of this trial is to determine overall survival for subjects with colorectal cancer and incurable metastatic liver disease who fail at least first line chemotherapy and are treated with radiofrequency ablation plus additional chemotherapy compared to subjects receiving additional chemotherapy only
The current gold standard in the treatment of isolated metastatic liver disease is curative hepatic resection Only within the last 20 years has surgical resection become a viable option as in the past it was considered unjustified due to high morbidity and mortality rates The primary drawback to hepatic resection is the sheer number of patients for whom it is contraindicated Only 10-20 of patients liver metastases are candidates for surgical resection owing to factors such as tumor locations size extent of disease and other medical co-morbidities
Historically in cases where hepatic resection was contraindicated systemic chemotherapy was the only alternative treatment In the last several years an increasing number of hepatic directed therapies have become available such as hepatic artery ligation radiation hepatic artery infusion of chemotherapy chemoembolization and mechanical ablation of the tumors
One mechanical method of ablation involves the use of radiofrequency thermal technology also called radiofrequency ablation RFA The RFA procedure involves inserting an RF electrode into the center of a hepatic tumor mass under ultrasonic or CT guidance Radiofrequency energy is then applied through the electrode causing a thermal injury to the surrounding tumor tissue Currently there are two basic designs for monitoring inter-procedural progress during RFA temperature monitoring of set points within the target tissue with thermocouples or assessing the system-wide impedance of tissue adjacent to the deployed electrode tines Radiofrequency ablation systems are comprised of three components a radiofrequency generator an active electrode and dispersive electrodes
To date no prospective multi-center trials have been completed which would conclusively demonstrate whether RFA is an effective adjunct to systemic chemotherapy with respect to advantages in median overall survival compared with chemotherapy alone The primary objective of this trial is to determine overall survival for subjects with colorectal cancer and incurable metastatic liver disease who fail at least first line chemotherapy and are treated with radiofrequency ablation plus additional chemotherapy compared to subjects receiving additional chemotherapy only
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