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

Not Applicable

Recruiting

• Conditions: Small-cell Lung Cancer
• Interventions: Radiation: Proton-beam Therapy for Small Cell Lung Cancer

• Registration Number: NCT04342429
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-19
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-05-27
• Study Completion: 2026-05-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective Study of Intensity-Modulated Proton Therapy (IMPT)	Proton-beam Therapy for Small Cell Lung Cancer	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.

Primary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States