Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
ConditionSmall-cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Proton-beam Therapy for Small Cell Lung Cancer
RadiationThe goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prospective Study of Intensity-Modulated Proton Therapy (IMPT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 start2
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 yearsSponsors and contacts
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Source ClinicalTrials.gov