Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
lung tumors, central airways
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Stereotactic Body Radiation Type: Radiation
Name: Radiofrequency Ablation Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy

- Tumors < 2 cm from trachea or zone of proximal bronchial tree (central tumors)

- Each tumor < 5 cm in size prior to treatment

- Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery

- Criterion for medical inoperability include:

- Overall clinical assessment at the UCLA thoracic tumor board

- Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below:

- Modified ACOSOG Criteria for medical inoperability:

- Major Criteria: FEV1% < 50% or < 1L and DLCO < 50%

- Minor Criteria: Age > 75, FEV1 51-60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF < 40% or less), resting or exercise arterial pO2 < 55 mmHg, and pCO2 > 45 mmHg

- Age > 18 years old

- KPS > 70

- If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Prior thoracic radiation near the targets of interest

- More than 2 central tumor targets per patient

- Active infections requiring systemic antibiotics
Location
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Status: Recruiting
Contact: Percy Lee, MD - 310-206-6542
Start Date
February 2010
Sponsors
Jonsson Comprehensive Cancer Center
Source
Jonsson Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page