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

Mass General Brigham

Status and phase

Completed

Phase 2

Phase 1

Conditions

Mesenchymal Tumor

Treatments

Radiation: Interoperative radiation

Radiation: Photon Beam Radiation

Radiation: Proton Beam Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00592345

97-502

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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