Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
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To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
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To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) 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
The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.
|
Outcome Measures
Primary Outcome Measures
- Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). [Up to 1 year from study start]
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.
- Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning [Up to 1,2, and 5 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed small cell lung cancer, limited or extensive stage.
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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.
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Age 18 or greater
Exclusion Criteria:
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Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
Investigators
- Principal Investigator: Kristin Higgins, MD, Emory University-Winship Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00110109