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

NCT ID: NCT04342429

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-19

Study Completion Date

2027-05-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Small-cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Proton-beam Therapy for Small Cell Lung Cancer

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Sibo Tian

Principal Investigator, Associate Professor, Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Higgins, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University-Winship Cancer Institute

Locations

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Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristin Higgins, MD

Role: CONTACT

404-778-0603

Allyson Anderson

Role: CONTACT

404-251-2854

Facility Contacts

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Kristin Higgins, MD

Role: primary

404-778-0603

Allyson Anderson

Role: backup

404-251-2854

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00110109

Identifier Type: -

Identifier Source: org_study_id

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