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

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

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

Study Overview

• Status: Recruiting
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Radiation: Proton-beam Therapy for Small Cell Lung Cancer

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allyson Anderson; Phone Number: 404-251-2854; Email: allyson.anderson@emory.edu
• Study Contact Backup: Name: Kristin Higgins, MD; Phone Number: 404-778-0603; Email: kristin.higgins@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Winship Cancer Institute
      • Contact: Allyson Anderson; Phone Number: 404-251-2854; Email: allyson.anderson@emory.edu
      • Contact: Kristin Higgins, MD; Phone Number: 404-778-0603; Email: kristin.higgins@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Kristin Higgins, MD, Emory University-Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Estimated): May 27, 2025
• Study Completion (Estimated): May 27, 2026

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: IRB00110109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes