Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

Study Overview
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Brief Summary
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To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

Detailed Description
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To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer). To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment. To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.

Official Title
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RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

Conditions
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Small-cell Lung Cancer

Intervention / Treatment
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* Radiation: Proton-beam Therapy for Small Cell Lung Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed small cell lung cancer, limited or extensive stage. Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist. Age 18 or greater Exclusion Criteria: Prior radiation therapy which would provide significant dose overlap with the planned target volume(s) Pregnancy

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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Accepts Healthy Volunteers

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: Prospective Study of Intensity-Modulated Proton Therapy (IMPT)<br>This is the first prospective study to investigate the safety and efficacy of IMPT for the treatment of SCLC. We will utilize adaptive planning throughout the radiation course. In addition, we will study the dosimetric parameters of IMPT and their correlation with treatment-related toxicities, particularly cardiac events. | Radiation: Proton-beam Therapy for Small Cell Lung Cancer<br>* The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). | Patients enrolled will experience <35% incidence of cardiac events at 1-year. Cardiac events included are acute heart disease, acute myocardial infarction, cardiomyopathy, dysrhythmia, heart failure, pericarditis, and pericardial effusion. | Up to 1 year from study start | 
| Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning | The optimal frequency of conebeam CT during treatment will be determined by a mixed model: The local control, distant metastases, patterns of failure will be summarized as frequency and percentage. Chi-square test will be used to test their relationships with other categorical variables. General linear model will be used to measure their association with continuous covariates with and without adjusting for other factors | Up to 1,2, and 5 years |