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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mesenchymal Tumor

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Thomas F. DeLaney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

97-502

NCT ID:

NCT00592345

Start Date:

May 1999

Completion Date:

Related Keywords:

  • Mesenchymal Tumor
  • sarcoma of the thoracic/lumbar/spine/sacrum
  • paraspinal soft tissues
  • proton radiation therapy
  • photon radiation therapy
  • radiation applicator plaque
  • Sarcoma

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617