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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
Must not have
Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease
Previous treatment with radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My cancer is a non-rhabdomyosarcoma soft tissue sarcoma or bone sarcoma, confirmed by biopsy.
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I have received standard chemotherapy if it was recommended for my condition.
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I am 30 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have health conditions that make radiation unsafe for me.
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I have undergone radiation therapy before.
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I am planned to receive adriamycin or gemcitabine chemotherapy, unless I am on another specific treatment protocol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Acute and late toxicities
Local Control
Secondary study objectives
Dosimetric Comparison

Side effects data

From 2017 Phase 1 & 2 trial • 50 Patients • NCT00438256
100%
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?

National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,444 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,875 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,843,396 Total Patients Enrolled
Boston Children's HospitalOTHER
788 Previous Clinical Trials
5,582,501 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,110 Previous Clinical Trials
358,228 Total Patients Enrolled
Torunn Yock, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
710 Total Patients Enrolled

Media Library

Proton Beam Radiation (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00592293 — N/A
Proton Beam Radiation (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00592293 — N/A
Soft Tissue Sarcomas Research Study Groups: Proton Beam Radiation
Soft Tissue Sarcomas Clinical Trial 2023: Proton Beam Radiation Highlights & Side Effects. Trial Name: NCT00592293 — N/A
~6 spots leftby Sep 2026
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