Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
June 16, 2025 updated by: Torunn Yock, MD, Massachusetts General Hospital
The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
- Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment.
- A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Biopsy proven Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) or bone sarcoma
- Less than or equal to 30 years of age
- Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated
- Patients must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment
- They or their legal guardian must give their informed consent
- Timing of radiation may be according to concurrent protocol
Exclusion Criteria:
- Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease
- Patients who are pregnant
- Previous treatment with radiation therapy
- Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Proton Beam Radiation
|
Once per day, 5 days a week for a total of 4 to 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment
Time Frame: 5 years from the completion of radiation treatment
|
Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity.
Late complications are defined as the delayed effects attributable to radiation which occur > 90 days following completion of radiation.
|
5 years from the completion of radiation treatment
|
|
Local Control
Time Frame: 5 years from the start of radiation treatment
|
Rates of local control using proton radiotherapy.
Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred.
|
5 years from the start of radiation treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dosimetric Comparison
Time Frame: 5 years
|
Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Torunn Yock, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2006
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
December 28, 2007
First Posted (Estimated)
January 14, 2008
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
June 16, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-326
- Other (Other Identifier: GENERATION HD2)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.