Trial record 1 of 1 for:
NCT01325753
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This study has been withdrawn prior to enrollment.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:
Comprehensive Cancer Center of Wake Forest University
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
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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 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 Neoplasm Metastasis Small Cell Lung Carcinoma Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013