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NCT Number: NCT04342429

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)

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).

    Time frame: 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.

  2. Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Allyson Anderson

CONTACT

[email protected]

404-251-2854

Kristin Higgins, MD

CONTACT

[email protected]

404-778-0603

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2020
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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