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

Primary Purpose

Liver Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Ablation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring stage III childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, liver metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of unresectable malignant primary or metastatic liver tumors Tumors are deemed unresectable based on the following factors: 1-10 liver tumors Bilobar liver tumors Location of 1 or more lesions near a major intrahepatic vascular structure (hepatic vein, portal vein, vena cava) Severe cirrhosis to preclude a major liver resection No unresectable extrahepatic disease Prior failure of other therapeutic modalities allowed No more than moderate ascites No hepatic encephalopathy PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: No severe liver dysfunction (Child's Class C) Bilirubin no greater than 3.0 mg/dL Albumin no greater than 3.0 mg/dL PT no greater than 50% above normal Renal: No renal dysfunction Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No altered mental status No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heat Therapy

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
November 2, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004136
Brief Title
Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Official Title
A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 9, 1998 (Actual)
Primary Completion Date
January 25, 2006 (Actual)
Study Completion Date
January 25, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Metastatic Cancer
Keywords
stage III childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heat Therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Other Intervention Name(s)
Heat Therapy
Intervention Description
Tumors heated to target temperature by electrodes for maximum of 20 minutes
Primary Outcome Measure Information:
Title
Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer
Time Frame
1 Month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of unresectable malignant primary or metastatic liver tumors Tumors are deemed unresectable based on the following factors: 1-10 liver tumors Bilobar liver tumors Location of 1 or more lesions near a major intrahepatic vascular structure (hepatic vein, portal vein, vena cava) Severe cirrhosis to preclude a major liver resection No unresectable extrahepatic disease Prior failure of other therapeutic modalities allowed No more than moderate ascites No hepatic encephalopathy PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: No severe liver dysfunction (Child's Class C) Bilirubin no greater than 3.0 mg/dL Albumin no greater than 3.0 mg/dL PT no greater than 50% above normal Renal: No renal dysfunction Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No altered mental status No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Curley, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website

Learn more about this trial

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

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