NCT01325753WithdrawnNot Applicable
A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Safety of interventional cryoablation to the lung
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
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
Arms & Interventions
Treatment (cryoablation)
Experimental
Patients undergo CT-guided CA.
Intervention: cryotherapy (Procedure)
Treatment (cryoablation)
Experimental
Patients undergo CT-guided CA.
Intervention: quality-of-life assessment (Procedure)
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)
Investigators
Similar Trials
Suspended
Not Applicable
Cryotherapy & OxaliplatinColon CancerPeripheral NeuropathyNCT06281925NYU Langone Health40
Terminated
Phase 2
Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant TherapyBreast CancerNCT01388777M.D. Anderson Cancer Center1
Completed
Not Applicable
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain SyndromeBreast CarcinomaNCT02640053Academic and Community Cancer Research United46
Active, not recruiting
Not Applicable
Registry of Patients Undergoing Cryoablation for Early Stage Breast CancerEarly Stage Breast CarcinomaNCT06387173Jonsson Comprehensive Cancer Center2
Withdrawn
Phase 4
CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced ProctitisRadiation ProctitisRadiation Induced ProctitisNCT00756197CSA Medical, Inc.