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

A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Metastases; Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Recurrent Malignant Mesothelioma; Advanced Malignant Mesothelioma
• Intervention / Treatment: Procedure: quality-of-life assessment; Procedure: cryotherapy

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment (cryoablation); Patients undergo CT-guided CA.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: cryotherapy; Undergo CT-guided CA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of interventional cryoablation to the lung	Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: James Urbanic, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ANTICIPATED): March 1, 2013
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (ESTIMATE): March 30, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence; Small Cell Lung Carcinoma; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: IRB00015085; NCI-2011-00319 (REGISTRY: CTRP); CCCWFU 62210 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No