A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Malignant Mesothelioma
- Sponsor
- Wake Forest University Health Sciences
- Primary Endpoint
- Safety of interventional cryoablation to the lung
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Safety of interventional cryoablation to the lung
Time Frame: 6 months
Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Secondary Outcomes
- Local control measured by imaging(At 1 year)
- Changes in Physical function and quality of life(approximately 60 months)
- Changes in pulmonary function(At 3 months)
- Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial(approximately 60 months)