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


N/A
18 Years
N/A
Not Enrolling
Both
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


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.


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

Type of Study:

Interventional

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:

Yes

Principal Investigator

James Urbanic

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 62210

NCT ID:

NCT01325753

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

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