High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
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|ClinicalTrials.gov Identifier: NCT00592345|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : February 3, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Mesenchymal Tumor||Radiation: Proton Beam Radiation Radiation: Photon Beam Radiation Radiation: Interoperative radiation||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2016|
- 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.
- To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population. [ Time Frame: 3 years ]
- To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment. [ Time Frame: 3 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592345
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Thomas F. DeLaney, MD||Massachusetts General Hospital|
|Responsible Party:||Tom DeLaney, MD, Attending Radiation Oncologist, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||January 14, 2008 Key Record Dates|
|Last Update Posted:||February 3, 2017|
|Last Verified:||February 2017|
sarcoma of the thoracic/lumbar/spine/sacrum
paraspinal soft tissues
proton radiation therapy
photon radiation therapy
radiation applicator plaque
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type