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

NCT ID: NCT00592345

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31
• Study Completion Date: 2016-03-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Proton Beam Radiation

Administered over a period of 12 weeks.

Intervention Type: RADIATION

Photon Beam Radiation

Administered over a period of 12 weeks.

Intervention Type: RADIATION

Interoperative radiation

Radioactive plaque applied at the time of surgical removal of the tumor.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tom DeLaney, MD

Attending Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas F. DeLaney, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

97-502

Identifier Type: -

Identifier Source: org_study_id