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.
Procedure: quality-of-life assessment
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Full eligibility criteria for NCT01325753
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura.
Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease
The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures
Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side)
Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy
If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week
The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be
=< 3.5 cm in greatest dimension
All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient
Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60
Life expectancy > 3 months
Clinically suitable for cryoablation procedure as determined by the treating physician
Platelet count > 50,000/mm^3 within 60 days prior to study registration
International normalized ratio (INR) < 1.5 within 60 days prior to study registration
Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration
A signed study specific consent form is required
Primary lung cancer
Unable to lie flat or has respiratory distress at rest
Uncontrolled coagulopathy or bleeding disorders
Evidence of active systemic, pulmonary, or pericardial infection
Pregnant, nursing or wishes to become pregnant during the study
Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up
Currently participating in other experimental studies that could affect the primary endpoint
All locations for NCT01325753
View full eligibility
Tris trial is registered with FDA with number: NCT01325753. The sponsor of the trial is Wake Forest University Health Sciences and it is looking for 0 volunteers for the current phase.
Official trial title: A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
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