Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00024076

Collaborator

(none)

Enrollment

Location

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radiofrequency Ablation of Pulmonary Malignancy

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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