Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00024076
First received: September 13, 2001
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.


Condition Intervention Phase
Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Thymoma and Thymic Carcinoma
Procedure: radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of Pulmonary Malignancy

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 30
Study Start Date: May 2000
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
  • Determine the efficacy of this treatment, in terms of local control, in these patients.
  • Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.

OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.

Patients are followed at 1, 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of a primary or secondary intrathoracic malignancy

    • Any cell type or origin
    • Involving the intrapulmonary, mediastinal, or pleural/chest wall
    • Inoperable primary or metastatic cancer to the lung
  • Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
  • Single or multiple lesions that are non-contiguous with vital structures or organs such as:
  • Trachea
  • Heart
  • Aorta
  • Great vessels
  • Esophagus
  • Less than 5 cm in largest dimension
  • Accessible via percutaneous transthoracic route
  • Hepatic:

    • Coagulation profile normal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024076

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Robert D. Suh, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00024076     History of Changes
Other Study ID Numbers: CDR0000068889, P30CA016042, UCLA-9908024, NCI-G01-2011
Study First Received: September 13, 2001
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent non-small cell lung cancer
recurrent small cell lung cancer
recurrent malignant mesothelioma
recurrent thymoma and thymic carcinoma
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
pulmonary carcinoid tumor
lung metastases

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Neoplasm Metastasis
Lung Neoplasms
Thymoma
Carcinoma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Complex and Mixed
Thymus Neoplasms
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014