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Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas


Phase 2
N/A
30 Years
Open (Enrolling)
Both
Non-rhabdomyosarcoma Soft Tissue Sarcoma, Bone Sarcoma

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Trial Information

Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas


- Participants will receive radiation treatments once per day, 5 days a week for a total
of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation
doctor will see the participant once each week to monitor and record any side effects
they may have from radiation treatment.

- A special device will be made for each participant to help them hold still during the
treatment. This may either be a mask or foam cradle, depending on the area to be
treated.


Inclusion Criteria:



- Biopsy proven NRSTS or bone sarcoma

- Less than or equal to 30 years of age

- Patients must have been treated with a standardly accepted chemotherapy regimen if
chemotherapy is indicated

- Patients 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, the patient or guardian must be willing to have their
outside medical information released in order to track the results of treatment

- Timing of radiation may be according to concurrent protocol

Exclusion Criteria:

- Co-morbidities that would make the use of radiation too toxic to deliver safely, such
as serious local injury of collagen vascular disease

- Patients who are pregnant

- Previous treatment with radiation therapy

- Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent
protocol

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Acute and late toxicities

Outcome Description:

Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.

Outcome Time Frame:

3 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:

05-326

NCT ID:

NCT00592293

Start Date:

September 2006

Completion Date:

September 2016

Related Keywords:

  • Non-rhabdomyosarcoma Soft Tissue Sarcoma
  • Bone Sarcoma
  • proton beam radiation
  • Osteosarcoma
  • Sarcoma

Name

Location

Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617