RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Emory University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
Study Overview
Brief Summary
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
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).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Proton-beam Therapy for Small Cell Lung Cancer (Radiation)
Outcomes
Primary Outcomes
Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
Time Frame: 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
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sibo Tian
Principal Investigator, Associate Professor, Department of Radiation Oncology
Emory University