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Proton Beam Therapy
Proton Beam Radiation for Rhabdomyosarcoma
Phase 2
Recruiting
Led By Torunn Yock, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be treated with a standardly accepted chemotherapy regimen
Timing of radiation must be according to the IRB protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery
Must not have
Previous treatment with radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether proton beam radiation, which affects less healthy tissue than photon beam radiation, can reduce side effects from radiation treatment for rhabdomyosarcoma.
Who is the study for?
This trial is for children and young adults up to 21 years old with newly diagnosed rhabdomyosarcoma. They must be on a standard chemotherapy regimen and able to follow-up for five years post-treatment. It's not suitable for those with metastatic disease (except certain cases), previous radiation therapy, life-threatening co-morbidities, or if pregnant.
What is being tested?
The study tests proton beam radiation against the standard photon beam radiation in treating pediatric rhabdomyosarcoma. Proton radiation aims to minimize damage to healthy tissue by stopping at the tumor site rather than passing through it.
What are the potential side effects?
While specific side effects are not listed, proton beam radiation generally aims to reduce side effects compared to photon beam by limiting exposure of healthy tissues. Potential risks may still include skin reactions, fatigue, and other typical radiation-associated symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving a widely accepted chemotherapy treatment.
Select...
My radiation therapy is scheduled as per the approved plan, within 35 days of my last chemo or surgery.
Select...
I have been newly diagnosed with rhabdomyosarcoma.
Select...
I am 21 years old or younger.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have undergone radiation therapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Late toxicity
Secondary study objectives
Acute toxicity
Dosimetric comparison
Local Control
Side effects data
From 2017 Phase 1 & 2 trial • 50 Patients • NCT00438256100%
Fatigue
100%
Nausea
67%
Vomiting
67%
Abdomen- pain
33%
Constipation
33%
Anorexia
33%
Dehydration
33%
Bilirubin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Proton Beam Radiation/ Capecitabine Dose Level 1
Proton Beam Radiation/ Capecitabine Dose Level 3
Proton Beam Radiation/ Capecitabine Dose Level 4
Proton Beam Radiation/ Capecitabine Dose Level 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Proton Beam RadiationExperimental Treatment1 Intervention
Proton Beam Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation
2007
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,668 Previous Clinical Trials
11,876,153 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,829 Previous Clinical Trials
8,169,781 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
25 Patients Enrolled for Rhabdomyosarcoma
Boston Children's HospitalOTHER
788 Previous Clinical Trials
5,582,461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving a widely accepted chemotherapy treatment.I am aged 2-10 with a specific type of cancer, allowing for metastatic disease.My radiation therapy is scheduled as per the approved plan, within 35 days of my last chemo or surgery.I have health conditions that make radiation unsafe for me.I have undergone radiation therapy before.I have been newly diagnosed with rhabdomyosarcoma.I am receiving a widely accepted chemotherapy treatment.I am 21 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Beam Radiation
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.