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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00592345
Other study ID # 97-502
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 28, 2007
Last updated February 2, 2017
Start date May 1999
Est. completion date March 2016

Study information

Verified date February 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2016
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population. 3 years
Secondary To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment. 3 years
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