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Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Primary Purpose

Lung Cancer, Malignant Mesothelioma, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

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

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00024076
Brief Title
Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
Official Title
Radiofrequency Ablation of Pulmonary Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Malignant Mesothelioma, Metastatic Cancer, Thymoma and Thymic Carcinoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Suh, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

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