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A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Phase 2
21 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

- 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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Late toxicity

Outcome Description:

Frequency and severity of late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Torunn Yock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

October 2004

Completion Date:

December 2014

Related Keywords:

  • Rhabdomyosarcoma
  • pediatric rhabdomyosarcoma
  • proton radiation therapy
  • Rhabdomyosarcoma
  • Rhabdomyosarcoma, Embryonal



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Texas MD Anderson Cancer Center Houston, Texas  77030