Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

Not Applicable

Withdrawn

• Conditions: Lung Metastases; 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; Advanced Malignant Mesothelioma
• Interventions: Procedure: cryotherapy; Procedure: quality-of-life assessment

• Registration Number: NCT01325753
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Primary Completion: 2013-03
• Study Completion: 2017-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (cryoablation)	cryotherapy	Patients undergo CT-guided CA.
Treatment (cryoablation)	quality-of-life assessment	Patients undergo CT-guided CA.

Primary Outcome Measures

Name	Time	Method
Safety of interventional cryoablation to the lung	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 Outcome Measures

Name	Time	Method
Changes in pulmonary function	At 3 months	Measure by pulmonary function test
Local control measured by imaging	At 1 year	Measure definitions: * 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	approximately 60 months	Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial	approximately 60 months