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

Completed · Phase 1/Phase 2

Conditions studied: Mesenchymal Tumor

In brief

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.

Key facts

Study ID

NCT00592345

Run by

Massachusetts General Hospital

People needed

50

Starts

1999-05-01

Expected to finish

2016-03-01

Last updated by the study team

2017-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnancy
• Disease/conditions characterized by high radiation sensitivity. These include genetic diseases, such as ataxia telangiectasia. Major local conditions which are the local tolerance viz., multiple surgical procedures, serious local injuries.
• No evident cord/cauda malfunction for causes other than effects of local tumor growth or due to metabolic effects of tumor

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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