- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00024076
Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
Radiofrequency Ablation of Pulmonary Malignancy
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Robert D. Suh, MD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neoplasms, Complex and Mixed
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Lung Neoplasms
- Thymoma
- Thymus Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
Other Study ID Numbers
- CDR0000068889
- UCLA-9908024
- NCI-G01-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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