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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

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 • NCT00438256
100%
Fatigue
100%
Nausea
67%
Vomiting
67%
Abdomen- pain
33%
Constipation
33%
Dehydration
33%
Anorexia
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
1,666 Previous Clinical Trials
11,840,125 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,148 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
25 Patients Enrolled for Rhabdomyosarcoma
Boston Children's HospitalOTHER
784 Previous Clinical Trials
5,581,271 Total Patients Enrolled

Media Library

Proton Beam Radiation (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00592592 — Phase 2
Rhabdomyosarcoma Research Study Groups: Proton Beam Radiation
Rhabdomyosarcoma Clinical Trial 2023: Proton Beam Radiation Highlights & Side Effects. Trial Name: NCT00592592 — Phase 2
Proton Beam Radiation (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00592592 — Phase 2
~4 spots leftby Aug 2025
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