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.
Conditions:
🦠 Rhabdomyosarcoma
🗓️ Study Start (Actual) October 2004
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) August 2025
👥 Enrollment (Estimated) 110
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
    • * Patients less than or equal to 21 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.
Ages Eligible for Study: N/A to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 28 December 2007
  • First Submitted that Met QC Criteria 28 December 2007
  • First Posted 14 January 2008

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 January 2023
  • Last Update Posted 9 January 2023
  • Last Verified January 2023