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

NCT04342429 | Recruiting DMC FDA Device

• 1 other identifier: IRB00110109
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Prospective Study of Intensity-Modulated Proton Therapy (IMPT)

EXPERIMENTAL

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

Interventions

Proton-beam Therapy for Small Cell Lung Cancer RADIATION

The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.

Prospective Study of Intensity-Modulated Proton Therapy (IMPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Protons

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Kristin Higgins, MD

  Emory University-Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Higgins, MD

CONTACT

404-778-0603; kristin.higgins@emory.edu

Allyson Anderson

CONTACT

404-251-2854; allyson.anderson@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 13, 2020
• Study Start: March 19, 2020
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): May 27, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)