Trial record 1 of 1 for:    NCT01325753
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Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01325753
First received: March 28, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
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
Procedure: cryotherapy
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Safety of interventional cryoablation to the lung [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Local control measured by imaging [ Time Frame: At 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: approximately 60 months ] [ Designated as safety issue: No ]
    Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery

  • Changes in pulmonary function [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    Measure by pulmonary function test

  • Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial [ Time Frame: approximately 60 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (cryoablation)
Patients undergo CT-guided CA.
Procedure: cryotherapy
Undergo CT-guided CA
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325753

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: James Urbanic Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01325753     History of Changes
Other Study ID Numbers: CCCWFU 62210, NCI-2011-00319
Study First Received: March 28, 2011
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Small Cell Lung Carcinoma
Adenoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014