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

18 Years
Not Enrolling
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

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Trial Information

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


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).


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.


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of interventional cryoablation to the lung

Outcome Description:

Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

James Urbanic

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Institutional Review Board

Study ID:

CCCWFU 62210



Start Date:

March 2011

Completion Date:

March 2017

Related Keywords:

  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Mesothelioma
  • Neoplasm Metastasis
  • Small Cell Lung Carcinoma