Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2001

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00024076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Official Title ^ICMJE

Radiofrequency Ablation of Pulmonary Malignancy

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Thymoma and Thymic Carcinoma

Intervention ^ICMJE

Procedure: radiofrequency ablation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Coagulation profile normal

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00024076

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068889, UCLA-9908024, NCI-G01-2011

Study Sponsor ^ICMJE

Jonsson Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Robert D. Suh, MD

Jonsson Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP