Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
RATIONALE: Heating tumors to several degrees above body temperature may kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of heat therapy in treating patients who have unresectable primary or metastatic liver cancer.
|Liver Cancer Metastatic Cancer||Procedure: Radiofrequency Ablation||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors|
- Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer [ Time Frame: 1 Month ]
|Study Start Date:||November 1999|
|Study Completion Date:||January 2006|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
|Experimental: Heat Therapy||
Procedure: Radiofrequency Ablation
Tumors heated to target temperature by electrodes for maximum of 20 minutes
Other Name: Heat Therapy
OBJECTIVES: I. Determine the efficacy of radiofrequency ablation in patients with primary or metastatic liver cancer. II. Determine disease free survival, local recurrence rate in treated lesions as compared to known recurrence rates after hepatic cryoablation, and overall survival in this patient population receiving this regimen.
OUTLINE: Patients undergo laparoscopic or open laparotomy surgical procedure to identify unresectable tumors by ultrasound. Tumors are heated to a target temperature by electrodes for a maximum of 20 minutes. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment. Patients may be retreated if tumor recurs or new disease appears. Patients are followed at 1 month, every 3 months for the first 2 years, every 6 months for next 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 59 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004136
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Steven A. Curley, MD||M.D. Anderson Cancer Center|