Lung Cancer
Conditions
Keywords
lung tumors, central airways
Brief 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.
Interventions
RADIATIONStereotactic Body Radiation
3 fraction of stereotactic body radiation therapy within 10 days.
RADIATIONRadiofrequency Ablation
Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable). | 3 years |
| Progression-free survival | 3 years |
| Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA. | 3 years |
| Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury | 3 years |
| Concentration of serum VEGF as an early biomarker for response | 3 years |
| Overall survival | 3 years |
Countries
United States
Outcome results
None listed