Recruiting

IMPT

Sponsor:

Emory University

Code:

NCT04342429

Conditions

Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Proton-beam Therapy for Small Cell Lung Cancer

Study Details

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

Study ID

NCT04342429

Start date

Mar 19, 2020

Status verified date

Sep, 2026

Completion date

May 27, 2028

Anticipated

Primary completion date

May 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Kristin Higgins, MD

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

Allyson Anderson

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

Locations

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kristin Higgins, MD

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

Allyson Anderson

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

More Information

Sponsor

Emory University

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.