Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
NCT ID: NCT04342429
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2020-03-19
2027-05-27
Brief Summary
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Detailed Description
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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.
* To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Emory University
OTHER
Responsible Party
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Sibo Tian
Principal Investigator, Associate Professor, Department of Radiation Oncology
Principal Investigators
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Kristin Higgins, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University-Winship Cancer Institute
Locations
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Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00110109
Identifier Type: -
Identifier Source: org_study_id
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