Trial record 1 of 1 for:
NCT00280189
Study of Outcomes of Radiofrequency Ablation of Lung Tumors
This study is currently recruiting participants.
Verified February 2012 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Collaborator:
RITA Medical Systems
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00280189
First received: January 18, 2006
Last updated: February 22, 2012
Last verified: February 2012
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Prospective Study of Outcomes of Radiofrequency Ablation of Lung Tumors |
Resource links provided by NLM:
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 then annually ] [ 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 ]
| Estimated Enrollment: | 72 |
| Study Start Date: | September 2003 |
Intervention Details:
-
Procedure: Radiofrequency ablation of pulmonary malignancies
Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
Behavioral: Quality of life assessment
Quality of life assessment is administered prior to the Radiofrequency ablation procedure and every 3 months for 1 year following the procedure.
Behavioral: Assessment of pain
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.
Show Detailed Description
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: 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: Manisha Shende, MD | |
| Sub-Investigator: Katie Nason, MD | |
| Sub-Investigator: Omar Awais, MD | |
| Sub-Investigator: James Klena, MD | |
| Sub-Investigator: Joseph Wizorek, 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
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00280189 History of Changes |
| Other Study ID Numbers: | 0302108, #02-033 |
| Study First Received: | January 18, 2006 |
| Last Updated: | February 22, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013