Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

Phase 2

Completed

• Conditions: Metastatic Cancer; Liver Cancer
• Interventions: Procedure: Radiofrequency Ablation

• Registration Number: NCT00004136
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1998-03-09
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2004-08-19
• Study First Posted: 2004-08-20
• Primary Completion: 2006-01-25
• Study Completion: 2006-01-25
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heat Therapy	Radiofrequency Ablation	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer	1 Month

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States