Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

Study Overview
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Brief Summary
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The main objective of this study is to assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days) for patients with early stage lung cancer.

Official Title
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A Pilot Study of Interventional Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: thermal ablation with external beam radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AJCC sixth edition Stage Ib or II non-small-cell lung cancer with cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible. To be considered node negative for N2 disease, patients will have mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on FDG PET in those areas. All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to co-morbid conditions. The CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion is determined to be in a location where RFA is technically achievable based on the proximity of adjacent organs and structures. Age ≥ 18 years old Performance Status 0-2 (ECOG) Exclusion Criteria: History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry Previous chest radiation to the region of interest. Pregnant or lactating women. A clinical diagnosis of bronchoalveolar carcinoma (BAC) will be made for patients in whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the following radiographic criteria are met.

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: thermal ablation with external beam radiation<br> | Radiation: thermal ablation with external beam radiation<br>* thermal ablation with external beam radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days). |  | 2 years |