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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Bone Sarcoma
Non-rhabdomyosarcoma Soft Tissue Sarcoma

Treatments

Radiation: Proton Beam Radiation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00592293
05-326
Other (Other Grant/Funding Number)

Details and patient eligibility

About

The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.

Full description

  • 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.

Enrollment

70 patients

Sex

All

Ages

Under 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Biopsy proven Non-Rhabdomyosarcoma Soft Tissue Sarcoma (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
  • They or their legal guardian must give their informed consent
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Proton Beam Radiation
Experimental group
Description:
Proton Beam Radiation
Treatment:
Radiation: Proton Beam Radiation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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