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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00319 | Registry Identifier | CTRP | |
| CCCWFU 62210 | Other Identifier | Wake Forest University Health Sciences |
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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.
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cryoablation) | Experimental | Patients undergo CT-guided CA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryotherapy | Procedure | Undergo CT-guided CA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of interventional cryoablation to the lung | Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local control measured by imaging | Measure definitions:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Urbanic | Wake Forest University Health Sciences | Principal Investigator |
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| quality-of-life assessment |
| Procedure |
Ancillary studies |
|
|
| At 1 year |
| Changes in Physical function and quality of life | Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery | approximately 60 months |
| Changes in pulmonary function | Measure by pulmonary function test | At 3 months |
| Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial | approximately 60 months |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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