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

NCT ID: NCT01325753

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Advanced Malignant Mesothelioma; Extensive Stage Small Cell Lung Cancer; Lung Metastases; Recurrent Malignant Mesothelioma; Recurrent Non-small Cell Lung Cancer; Recurrent Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (cryoablation)

Patients undergo CT-guided CA.

Group Type: EXPERIMENTAL

cryotherapy

Intervention Type: PROCEDURE

Undergo CT-guided CA

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

Interventions

cryotherapy

Undergo CT-guided CA

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

Other Intervention Names

quality of life assessment

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Urbanic

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

NCI-2011-00319

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 62210

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00015085

Identifier Type: -

Identifier Source: org_study_id