Clinical trial · Interventional
Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma
A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Beam Radiation
- description
- Proton Beam Radiation
- interventionNames
- Radiation: Proton Beam Radiation
Primary outcomes (1)
- measure
- Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up
- timeFrame
- 5 years from the start of radiation treatment
- description
- 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.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available