NCT00004136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

August 20, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2006

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

7.9 years

First QC Date

December 10, 1999

Last Update Submit

November 2, 2018

Conditions

Liver CancerMetastatic Cancer

Keywords

stage III childhood liver cancerstage IV childhood liver cancerrecurrent childhood liver cancerlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancerliver metastases

Outcome Measures

Primary Outcomes (1)

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

    1 Month

Study Arms (1)

Heat Therapy

EXPERIMENTAL
Procedure: Radiofrequency Ablation

Interventions

Radiofrequency AblationPROCEDURE

Tumors heated to target temperature by electrodes for maximum of 20 minutes

Also known as: Heat Therapy
Heat Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm MetastasisCarcinoma, Hepatocellular

Interventions

Radiofrequency AblationDiathermy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeHyperthermia, Induced

Study Officials

  • Steven A. Curley, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

August 20, 2004

Study Start

March 9, 1998

Primary Completion

January 25, 2006

Study Completion

January 25, 2006

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

US(1)