RecruitingRecruiting
Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
NCT04342429 · Emory University
In plain English
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Official title
RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
About this study
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.
Eligibility criteria
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 design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-03-19
Estimated completion: 2028-05-27
Last updated: 2026-09-17
Interventions
Radiation: Proton-beam Therapy for Small Cell Lung Cancer
Primary outcomes
- • Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). (Up to 1 year from study start)
- • Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning (Up to 1,2, and 5 years)
Sponsor
Emory University · other
Contacts & investigators
ContactKristin Higgins, MD · contact · kristin.higgins@emory.edu · 404-778-0603
ContactAllyson Anderson · contact · allyson.anderson@emory.edu · 404-251-2854
InvestigatorKristin Higgins, MD · principal_investigator, Emory University-Winship Cancer Institute
All locations (1)
Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States