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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01325753
• Other study ID #: IRB00015085
• Secondary ID: NCI-2011-00319CC
• Status: Withdrawn
• Phase: N/A
• Start date: March 2011
• Est. completion date: March 2017

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignant Mesothelioma
• Carcinoma, Non-Small-Cell Lung
• Extensive Stage Small Cell Lung Cancer
• Lung Metastases
• Lung Neoplasms
• Mesothelioma
• Recurrent Malignant Mesothelioma
• Recurrent Non-small Cell Lung Cancer
• Recurrent Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Stage IV Non-small Cell Lung Cancer

Intervention

Procedure:
• cryotherapy
Undergo CT-guided CA
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in pulmonary function	Measure by pulmonary function test	At 3 months
Secondary	Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial		approximately 60 months