RhabdomyosarcomaNCT00592592
Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma
A study testing Proton Beam Radiation in people with Rhabdomyosarcoma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Rhabdomyosarcoma
- 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
- 115 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2004to Aug 2010
- 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
- Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
- Patients less than or equal to 30 years of age.
- Patients must be treated with a standardly accepted chemotherapy regimen.
- May not have metastatic disease unless aged 2-10 with embryonal histology.
- 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, they must be willing to have their outside medical information released to us to track the results.
- 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.
Who cannot join
- Life expectancy of less than 2 years.
- Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease.
- Patients who are pregnant
- Previous treatment with radiation therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.
Read the detailed description
- A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated.
- Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires.
- Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment.
- After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.
- Conditions
- Rhabdomyosarcoma
- Being tested
- Proton Beam Radiation
- Keywords
- pediatric rhabdomyosarcoma, proton radiation therapy
- Medical subject headings
- Rhabdomyosarcoma
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 Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up
Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.
Measured: 5 years from the start of radiation treatment
Secondary outcomes (3)
Percentage of Participants Who Experienced an Acute Toxicity by Grade
Percentage of participants who experienced an acute toxicity following completion of radiation treatment by grade. Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. The recommended evaluation time for acute toxicity after radiotherapy was 6 weeks following completion, but may be at any time during the 3 months after treatment. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.
Measured: 3 months from radiation treatment
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. Percent of normal tissue spared was calculated using the following equation: (100 x (mean x-ray dose - mean proton dose))/mean X-ray dose. No measure of dispersion was calculated for these estimates. The data is no longer available.
Measured: 4 years from the start of radiation treatment
Local Control
Estimated survival probability (defined as being free of a local recurrence) was calculated using Grays formula for competing risks
Measured: 5 years from the start of radiation therapy
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 startOct 2004
- Primary completionAug 2010
- Study completionAug 2010
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 RhabdomyosarcomaStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH), National Cancer Institute (NCI)
- 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
- NCT00592592
- Sponsor's protocol ID
- 04-188
- Other IDs
- P01CA021239
- Status last verified
- Jun 2025
- First submitted
- 28 Dec 2007
- Last updated
- 18 Jun 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
- ClinicalTrials.gov ID
- NCT00592592
- Acronym / sponsor ID
- 04-188
- Conditions
- Rhabdomyosarcoma
- Keywords
- pediatric rhabdomyosarcoma, proton radiation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Oct 2004 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Posted 18 Jun 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 see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.
Detailed description
- A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated.
- Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires.
- Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment.
- After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.
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)
- Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
- Patients less than or equal to 30 years of age.
- Patients must be treated with a standardly accepted chemotherapy regimen.
- May not have metastatic disease unless aged 2-10 with embryonal histology.
- 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, they must be willing to have their outside medical information released to us to track the results.
Key exclusion criteria (4 listed)
- Life expectancy of less than 2 years.
- Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease.
- Patients who are pregnant
- Previous treatment with radiation therapy.
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 Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up
Time frame: 5 years from the start of radiation treatment
Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.
3 secondary outcomes
Percentage of Participants Who Experienced an Acute Toxicity by Grade
Time frame: 3 months from radiation treatment
Dosimetric Comparison
Time frame: 4 years from the start of radiation treatment
Local Control
Time frame: 5 years from the start of radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcomaLink provided by the sponsor.
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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
3 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 Rhabdomyosarcoma, run by Massachusetts General Hospital at 3 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 18 Jun 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 Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up (time frame: 5 years from the start of radiation treatment). 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 18 Jun 2025.