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

Primary Purpose

Small-cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton-beam Therapy for Small Cell Lung Cancer
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective Study of Intensity-Modulated Proton Therapy (IMPT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2020
Last Updated
February 21, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT04342429
Brief Title
Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Official Title
RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
May 27, 2024 (Anticipated)
Study Completion Date
May 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective Study of Intensity-Modulated Proton Therapy (IMPT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Proton-beam Therapy for Small Cell Lung Cancer
Intervention Description
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 Information:
Title
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
Description
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.
Time Frame
Up to 1 year from study start
Title
Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
Description
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
Time Frame
Up to 1,2, and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Higgins, MD
Phone
404-778-0603
Email
kristin.higgins@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Allyson Anderson
Phone
404-251-2854
Email
allyson.anderson@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Higgins, MD
Organizational Affiliation
Emory University-Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Higgins, MD
Phone
404-778-0603
Email
kristin.higgins@emory.edu
First Name & Middle Initial & Last Name & Degree
Allyson Anderson
Phone
404-251-2854
Email
allyson.anderson@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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