Study of Outcomes of Radiofrequency Ablation of Lung Tumors - Full Text View

Sponsors and Collaborators:	University of Pittsburgh RITA Medical Systems
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00280189

Purpose

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) of pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Condition	Intervention
NSCLC Pulmonary Metastases	Procedure: Radiofrequency ablation of pulmonary malignancies Behavioral: Quality of life assessment Behavioral: Assessment of pain

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Prospective Study of Outcomes of Radiofrequency Ablation of Lung Tumors

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Assess overall survival, progression-free survival and clinical response after RFA for two groups of patients: patients with pulmonary metastases [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize QOL before and after RFA treatment [ Time Frame: Every 3 months for 1 year ] [ Designated as safety issue: No ]
To assess procedure related outcomes after RFA of lung tumors, in particular, measuring length of stay, morbidity and mortality and requirements for chest tube drainage [ Time Frame: Within 30 days of RFA procedure ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	72
Study Start Date:	September 2003

Intervention Details:

Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.

Quality of life assessment is administered prior to the Radiofrequency ablation procedure and every 3 months for 1 year following the procedure.

Pain scores are obtained prior to the procedure, daily X 7 starting on the day of surgery, and then every 3 months for 1 year.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients seeking minimally invasive treatment for pulmonary malignancies.

Criteria

Inclusion Criteria:

Have stage I or II primary lung cancer and who are felt not to be candidates for resection based upon co-morbid disease or who refuse lung resection.
Have metastatic tumors to the lung, and who meet criteria for metastasectomy but who are felt not to be candidates for resection of all metastases. All metastases should be treatable by RFA alone or in combination with resection.
Have positive tissue diagnosis by previous resection (less than 6 months) or by radiologic biopsy.
Have clinically suspicious disease defined as a new lesion on chest CT or a suspicious PET scan.
Have RF ablation target lesions of 4 centimeters or less in diameter.

Exclusion Criteria:

If the lesion is centrally located, less than 3 centimeters from the hilum.
If the target lesion is greater than 4 centimeters in diameter.
If the lesion is metastatic and the primary site is not controlled.
If extra-thoracic metastatic disease is present.
If there are more than 3 tumors in one lung.
If there are greater than 6 metastatic tumors in total (bilateral).
If it is felt that all metastases cannot be treated by RFA alone or in combination with resection.
If the patient is pregnant or nursing at the time of the procedure.
If the patient has malignant pleural effusion.
If the patient is unwilling or unable to provide consent for the procedure.
If the patient is less than 18 years of age (the short form [SF]-36 is not designed for patients less than 18 years of age).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280189

Contacts

Contact: James Luketich, MD	412-647-7555
Contact: Julie Ward, BSN	412-647-8583

Locations

United States, Pennsylvania
Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: James Luketich, MD 412-647-7555
Principal Investigator: James Luketich, MD
Sub-Investigator: Rodney J Landreneau, MD
Sub-Investigator: Neil A Christie, MD
Sub-Investigator: Miguel F Alvelo-Rivera, MD
Sub-Investigator: Sebastien Gilbert, MD
Sub-Investigator: Diane C Strollo, MD
Sub-Investigator: David Wilson, MD
Sub-Investigator: Norbert Avril, MD
Sub-Investigator: William E Gooding, MS
Sub-Investigator: Ghulam Abbas, MD
Sub-Investigator: Arjun Pennathur, MD
Sub-Investigator: Matthew Schuchert, MD
Sub-Investigator: Brian Pettiford, MD
Sub-Investigator: Manisha Shende, MD

Sponsors and Collaborators

University of Pittsburgh

RITA Medical Systems

Investigators

Principal Investigator:

James Luketich, MD

UPMC - Heart, Lung, and Esophageal Surgery Institute

More Information

Responsible Party:	University of Pittsburgh ( James Luketich, MD )
Study ID Numbers:	0302108, #02-033
Study First Received:	January 18, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00280189
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Radiofrequency ablation
Pulmonary malignancies
Primary lung cancer
Pulmonary metastasis

Primary lung tumors
Secondary lung tumors
Coagulation necrosis of soft tissue tumors

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Necrosis
Soft Tissue Neoplasms

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009