Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004136|
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : July 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Metastatic Cancer||Procedure: Radiofrequency Ablation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||April 2000|
|Actual Study Completion Date :||January 2006|
|Experimental: Heat Therapy||
Procedure: Radiofrequency Ablation
Tumors heated to target temperature by electrodes for maximum of 20 minutes
Other Name: Heat Therapy
- Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer [ Time Frame: 1 Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|