Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation
* Radiation: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up. | Radiation: Stereotactic Body Radiation<br>* 3 fraction of stereotactic body radiation therapy within 10 days.<br>* Other names: SBR;Radiation: Radiofrequency Ablation<br>* Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.<br>* Other names: RFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA. |  | 3 years | 
| 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 | 
| Overall survival |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung tumors, central airways