NCT04342429 · Emory University
Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
What this study is about
To assess the safety and effectiveness of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
View original scientific description
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
Interventions
RADIATION
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.
Primary outcome measures
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2025 · Source of record for eligibility and locations