Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

Small-cell Lung Cancer Clinical Trial

Official title:

RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342429
• Other study ID #: IRB00110109
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2020
• Est. completion date: May 27, 2026

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: Kristin Higgins, MD
• Phone: 404-778-0603
• Email: kristin.higgins[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 27, 2026
• Est. primary completion date: May 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year from study start
Primary	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	Up to 1,2, and 5 years