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Proton Beam Therapy
Proton Therapy for Small Cell Lung Cancer
N/A
Recruiting
Led By Kristin Higgins, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or greater
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1,2, and 5 years
Awards & highlights
Study Summary
This trial tests a new way to treat small cell lung cancer using proton therapy. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for adults over 18 with small cell lung cancer (SCLC), either limited or extensive stage, who are recommended to undergo thoracic radiotherapy using intensity-modulated proton therapy (IMPT) delivering specific doses. Pregnant individuals or those who have had prior radiation that overlaps with the target area cannot participate.Check my eligibility
What is being tested?
The study is examining the safety and effectiveness of a type of targeted radiation called intensity-modulated proton therapy (IMPT) in treating patients with small cell lung cancer. The IMPT will be administered in specified doses and number of sessions.See study design
What are the potential side effects?
Potential side effects from IMPT may include skin reactions, fatigue, difficulty swallowing, shortness of breath, coughing, and other localized symptoms due to the precise nature of proton beam targeting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am recommended to undergo a specific type of chest radiation therapy.
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My lung cancer is confirmed to be small cell type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1,2, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1,2, and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prospective Study of Intensity-Modulated Proton Therapy (IMPT)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,666 Total Patients Enrolled
Kristin Higgins, MDPrincipal Investigator - Emory University-Winship Cancer Institute
Emory Saint Joseph's, Emory University Hospital, Emory University Hospital Midtown, Grady Memorial Hospital
Tulane University School Of Medicine (Medical School)
4 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am recommended to undergo a specific type of chest radiation therapy.My lung cancer is confirmed to be small cell type.I've had radiation therapy that overlaps with the area planned for my current treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Prospective Study of Intensity-Modulated Proton Therapy (IMPT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment in need of participants at the moment?
"Affirmative. According to clinicaltrials.gov, this experiment has been open for recruitment since March 19th 2020 and the details were last updated on February 18th 2022. There is an urgent need for 30 participants at a single site."
Answered by AI
What is the upper limit for enrollment in this medical research endeavor?
"Affirmative, the facts hosted on clinicaltrials.gov shows that this medical experiment is presently accepting applicants. The trial was first published on March 19th 2020 and edited for the last time on February 18th 2022. This study will require 30 participants from 1 location to be recruited."
Answered by AI
Who else is applying?
What site did they apply to?
Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
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