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

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Sarcoma
NCT ID: NCT00592293 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 05-326

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Torunn Yock, MD, Massachusetts General Hospital

Site-responsible Investigators:
Karen Marcus, MD, Brigham and Women's Hospital

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

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
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