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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00592345
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mesenchymal Tumor Radiation: Proton Beam Radiation Radiation: Photon Beam Radiation Radiation: Interoperative radiation Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
More Information
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Responsible Party: Tom DeLaney, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592345    
Other Study ID Numbers: 97-502
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Keywords provided by Tom DeLaney, MD, Massachusetts General Hospital:
sarcoma of the thoracic/lumbar/spine/sacrum
paraspinal soft tissues
proton radiation therapy
photon radiation therapy
radiation applicator plaque
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms