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Proton Beam Therapy
Proton Radiation for Pediatric Sarcoma
N/A
Waitlist Available
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
Biopsy proven NRSTS or bone sarcoma
Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will study the effects of proton beam radiation on children with bone or non-rhabdomyosarcoma soft tissue sarcomas.
Who is the study for?
This trial is for children and young adults up to 30 years old with bone sarcoma or non-rhabdomyosarcoma soft tissue sarcomas. They must have had standard chemotherapy if needed, agree to long-term follow-up at MGH, and provide informed consent. Pregnant individuals, those planning certain chemotherapies, or with conditions making radiation unsafe are excluded.Check my eligibility
What is being tested?
The study is examining the effects of proton beam radiation therapy on pediatric patients with specific types of sarcomas. It aims to understand both immediate and long-term side effects from this treatment over a minimum five-year follow-up period.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of proton beam radiation may include skin reactions at the treatment site, fatigue, hair loss near treated areas, and potential damage to nearby healthy tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a non-rhabdomyosarcoma soft tissue sarcoma or bone sarcoma, confirmed by biopsy.
Select...
I have received standard chemotherapy if it was recommended for my condition.
Select...
I am 30 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute and late toxicities
Local Control
Secondary outcome measures
Dosimetric Comparison
Side effects data
From 2017 Phase 1 & 2 trial • 50 Patients • NCT00438256100%
Fatigue
100%
Nausea
67%
Vomiting
67%
Abdomen- pain
33%
Anorexia
33%
Dehydration
33%
Constipation
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
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?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,518 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,285 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,807 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have health conditions that make radiation unsafe for me.I have undergone radiation therapy before.My cancer is a non-rhabdomyosarcoma soft tissue sarcoma or bone sarcoma, confirmed by biopsy.I have received standard chemotherapy if it was recommended for my condition.I am 30 years old or younger.I am planned to receive adriamycin or gemcitabine chemotherapy, unless I am on another specific treatment protocol.
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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for this clinical experiment?
"Looking at the clinicaltrials.gov website, it appears that this trial is no longer accepting patients. Although first posted on October 1st 2006 and last modified on September 30th 2021, 445 other trials are actively recruiting as of right now."
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