Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases
Withdrawn before enrolling · Phase 4
Conditions studied: Metastatic Liver Cancer, Secondary Liver Cancer, Liver Neoplasm
In brief
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.
Key facts
- Study ID
- NCT00510627
- Run by
- Boston Scientific Corporation
- People needed
- 0
- Starts
- 2007-08-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All subjects must meet the following criteria:
- Subject must have incurable metastatic colorectal cancer with metastatic disease to the liver
- Subject must have extrahepatic metastatic disease, as confirmed by radiographic evidence or surgical/other documentation that cannot be treated by surgery or image guided therapy to an endpoint of no evidence of residual disease by imaging criteria
- Subject has received and, in the opinion of the treating physician, progressed through at least one prior chemotherapy regimen for metastatic disease, or has developed recurrent disease on or within 6 months of completing adjuvant therapy
- At least 50% of the total tumor burden is in the liver, as determined by the treating investigator, and prior to any study specified intervention (resection or ablation).
- Subject must have no more than 10 hepatic tumors remaining after surgical resection, with no tumor exhibiting a unidimensional size greater than 5cm
- Subject is medically eligible to receive RFA, as determined by the treating investigator
- Subject is naïve to, and medically eligible (as defined by the treating investigator) to receive, at least one of the following:
- an oxaliplatin containing regimen
- an irinotecan containing regimen
- an anti-EGFR monoclonal antibody-containing regimen (subject must be naïve to both cetuximab and panitumumab)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age > 18 years
- Subject life expectancy > 3 months
- International Normalized Ratio (INR) < 2.0
- Platelets > 100 x103/mm3
- Total Bilirubin <1.5mg/dl
- Creatinine level < 2.0 mg/dl
- Must sign an Informed Consent form
You may not qualify if…
- All subjects who meet any of the following criteria will not be enrolled into the study:
- Subjects's extrahepatic disease is amenable to curative surgical or image guided therapy
- Subject has known brain metastases
- Uncorrectable coagulopathy
- Subject is pregnant, nursing, or wishes to become pregnant during the study
- Other serious medical condition(s) (e.g. uncontrolled infection, uncontrolled cardiac disease) that, in the opinion of the treating investigator, would preclude study treatment or impact survival.
- Current or planned treatment with any experimental chemotherapy or biological agents
Where it is running
- New York University — New York, New York, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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