A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
N/A
21 Years
Both
Rhabdomyosarcoma
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:
Interventional
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:
Yes
Principal Investigator
Torunn Yock, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
04-188
NCT ID:
NCT00592592
Start Date:
October 2004
Completion Date:
December 2014
Related Keywords:
- Rhabdomyosarcoma
- pediatric rhabdomyosarcoma
- proton radiation therapy
- Rhabdomyosarcoma
- Rhabdomyosarcoma, Embryonal
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
