NCT00592345

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* In this study three types of radiation will be used: standard radiation (called photon); alternative form of radiation called proton beam therapy; and a localized radiation applicator plaque that can be applied to the surface of the dura (the fibrous outer envelope that surrounds the spinal cord and fluid surrounding the spinal cord) at time of surgical removal of the tumor. * Radiation treatments (photon and proton) and possibly surgical removal of portions of the tumor with intraoperative radiation delivery to the surface dura with intraoperative radiation delivery will be performed over a period of 12 weeks. As part of the treatment planning process, participants will need two treatment planning CT scans and 2-3 treatment planning sessions. * Participants will receive, in total, 39-43 photon/proton treatments.

Conditions

• Mesenchymal Tumor

Interventions

Type	Name	Description
RADIATION	Proton Beam Radiation	Administered over a period of 12 weeks.
RADIATION	Photon Beam Radiation	Administered over a period of 12 weeks.
RADIATION	Interoperative radiation	Radioactive plaque applied at the time of surgical removal of the tumor.

Timeline

• Start date: 1999-05-01
• Primary completion: 2005-03-01
• Completion: 2016-03-01
• First posted: 2008-01-14
• Last updated: 2017-02-03

Locations

1 site across 1 country: United States