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

NCT ID: NCT04342429Sponsor: Emory UniversityLast updated: 2025-07-15

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.

Arms & interventions

  • RadiationProton-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

  • 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.

    Time frame: 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

    Time frame: Up to 1,2, and 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

Winship Cancer Institute

Atlanta, Georgia, 30322

Recruiting
Kristin Higgins, MD · Contact
404-778-0603kristin.higgins@emory.edu
Allyson Anderson · Contact
404-251-2854allyson.anderson@emory.edu
Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer | Cancerify