Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways
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