Small-cell Lung Cancer
Conditions
Brief 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.
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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). | 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 | 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 |
Countries
United States
Contacts
CONTACTKristin Higgins, MD
CONTACTAllyson Anderson
PRINCIPAL_INVESTIGATORKristin Higgins, MD
Emory University-Winship Cancer Institute
Outcome results
None listed