High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum

Status: Completed
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to test the effectiveness of high dose radiation administered by both proton and photon therapy. Radiation is an effective treatment for many types of tumors and it is thought that radiation alone, when given in much higher doses over a shorter period of time, may be more effective in controlling recurrence of sarcoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Pathological diagnosis of malignant mesenchymal tumor of the thoracic/lumbar/spine/sacrum or paraspinal soft tissues involving nerve roots or extending into spinal canal. Inter-osseous bone sarcomas are to be managed by wide resectional surgery for patients that are medically operable.

• Patient tumor status: 1) post biopsy or post resection with gross residual disease 2) post grossly complete resection but with margins positive or very close or tumor spill or cut through

• Lesion may be primary or recurrent after prior surgery

• No clinical, radiographic or other evidence of distant metastasis

• Fit for the exposure of the affected vertebral segment

• Life expectancy of greater than 36 months

• KPS equal to or greater than 70

• 18 years of age or older

• Declines radical surgery

• No prior radiation treatment to the affected spine region

Locations
United States
Massachusetts
Massachusetts General Hospital
Boston
Time Frame
Start Date: May 1999
Completion Date: March 2016
Participants
Target number of participants: 50
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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