Non-rhabdomyosarcoma Soft Tissue SarcomaNCT00592293
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
A study testing Proton Beam Radiation in people with Non-rhabdomyosarcoma Soft Tissue Sarcoma and Bone Sarcoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Non-rhabdomyosarcoma Soft Tissue Sarcoma, Bone Sarcoma
- What is being tested?
- Proton Beam Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2006to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Being tested
- Proton Beam Radiation
- Keywords
- proton beam radiation
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam RadiationRadiation
Once per day, 5 days a week for a total of 4 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Proton Beam Radiation | Experimental | Proton Beam Radiation Receives: Radiation: Proton Beam Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following 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.
Measured: 5 years from the completion of radiation treatment
Local Control
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.
Measured: 5 years from the start of radiation treatment
Secondary outcomes (1)
Dosimetric Comparison
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study start24 Oct 2006
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-rhabdomyosarcoma Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Torunn Yock, MD, Massachusetts General Hospital
- Investigators
- Torunn Yock, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592293
- Sponsor's protocol ID
- 05-326
- Other IDs
- Other
- Status last verified
- Jun 2025
- First submitted
- 28 Dec 2007
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00592293
- Acronym / sponsor ID
- 05-326
- Keywords
- proton beam radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH)
- Study start
- 24 Oct 2006 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Beam Radiation | Experimental | Radiation: Proton Beam RadiationProton Beam Radiation |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam RadiationOnce per day, 5 days a week for a total of 4 to 6 weeks. | Radiation | Proton Beam Radiation |
Primary outcome
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.
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.
1 secondary outcome
Dosimetric Comparison
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torunn Yock, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam Radiation in people with Non-rhabdomyosarcoma Soft Tissue Sarcoma and Bone Sarcoma, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment (time frame: 5 years from the completion of radiation treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.