Metastatic Liver Cancer Clinical Trial
— PrometheusOfficial 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
Verified date | March 2017 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | New York University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Berber E, Pelley R, Siperstein AE. Predictors of survival after radiofrequency thermal ablation of colorectal cancer metastases to the liver: a prospective study. J Clin Oncol. 2005 Mar 1;23(7):1358-64. — View Citation
Bowles BJ, Machi J, Limm WM, Severino R, Oishi AJ, Furumoto NL, Wong LL, Oishi RH. Safety and efficacy of radiofrequency thermal ablation in advanced liver tumors. Arch Surg. 2001 Aug;136(8):864-9. — View Citation
Chapter 49, Colon, Rectal, and Anal Cancers. PART VI: THE CARE OF INDIVIDUALS WITH SPECIFIC CANCERS; pp: 1156-1214
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DeMatteo RP, Fong Y, Blumgart LH. Surgical treatment of malignant liver tumours. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):557-74. Review. — View Citation
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Giantonio et. Al. High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200
Kemeny NE, Atiq OT. Non-surgical treatment for liver metastases. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):593-610. Review. — View Citation
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Poston GJ. Radiofrequency ablation of colorectal liver metastases: where are we really going? J Clin Oncol. 2005 Mar 1;23(7):1342-4. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate Overall Survival in subjects receiving chemotherapy + RFA compared to chemotherapy alone. | Study duration | ||
Secondary | To evaluate any unanticipated adverse device effects. | Two years | ||
Secondary | To determine if there are differences in the incidence or severity of adverse events in the RFA + chemotherapy arm compared to the chemotherapy only arm. | Study duration |
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