Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue. In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.

Detailed Description
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Subjects will undergo an electronic navigational bronchoscopy (ENB) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy. Subjects will receive a CT scan to obtain images to plan radiation treatment. Proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at Massachusetts General Hospital. After the final dose of proton radiation subjects will be followed for 5 years. Subjects will be asked to return at 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. Subjects will receive a chest CT, tumor assessment by CT or PET, chest x-ray, pulmonary function tests and a physical exam.

Official Title
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Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: SBRT with proton beam radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed) Stage clinical T1 N0 M0 or T2 N0 M0 NSCLC must be limited to a single lesion NSCLC must be peripherally located (> 2 cm from proximal bronchial tree and > 1 cm from mediastinal pleura) NSCLC must be considered medically inoperable Life expectancy greater than 6 months Exclusion Criteria: Pregnant or breastfeeding Prior radiation therapy to the lungs or mediastinum Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated Receiving other study agents or other types of cancer therapy Uncontrolled intercurrent illness Pacemaker or defibrillator-dependent

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: SBRT with proton beam radiation<br>4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of > 3 cm) | Radiation: SBRT with proton beam radiation<br>* 4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of > 3 cm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and safety | To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB) | 2 years | 
| Safety and tolerability | Frequency of radiation pneumonitis in participants treated with proton radiation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Describe the acute and late toxicities of treatment using CTCAE v4.0 | 2 years | 
| Efficacy | To describe radiological tumor responses | 2 years | 
| Disease Free survival | To calculate local, regional, and distant failure rates | 2 years | 
| Overall survival | To calculate the overall survival rate | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Lung Cancer