Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
Advanced Malignant Mesothelioma
Extensive Stage Small Cell Lung Cancer
Recurrent Malignant Mesothelioma
Recurrent Non-small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Procedure: quality-of-life assessment
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung|
- Safety of interventional cryoablation to the lung [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
- Local control measured by imaging [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
- Complete Response(tumor disappearance or less than 25% of original size)
- Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors)
- stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors)
- Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors)
- Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)
- Changes in Physical function and quality of life [ Time Frame: approximately 60 months ] [ Designated as safety issue: No ]Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
- Changes in pulmonary function [ Time Frame: At 3 months ] [ Designated as safety issue: No ]Measure by pulmonary function test
- Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial [ Time Frame: approximately 60 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cryoablation)
Patients undergo CT-guided CA.
Undergo CT-guided CAProcedure: quality-of-life assessment
Other Name: quality of life assessment
I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days).
I. Estimate local control.
II. To assess physical function for this cohort of patients.
III. To evaluate the impact of treatment on generic and disease-specific quality of life.
IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial.
V. Evaluate changes in pulmonary function at 3 months.
Patients undergo computed tomography (CT)-guided CA
After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325753
|Principal Investigator:||James Urbanic||Wake Forest School of Medicine|