Back to resultsHigh-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
Primary Purpose
Mesenchymal Tumor
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiation
Photon Beam Radiation
Interoperative radiation
Sponsored by
About this trial
This is an interventional treatment trial for Mesenchymal Tumor focused on measuring sarcoma of the thoracic/lumbar/spine/sacrum, paraspinal soft tissues, proton radiation therapy, photon radiation therapy, radiation applicator plaque
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
Sites / Locations
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.
Secondary Outcome Measures
To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment.
Full Information
NCT ID
NCT00592345
First Posted
December 28, 2007
Last Updated
February 2, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00592345
Brief Title
High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
Official Title
High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Tumor
Keywords
sarcoma of the thoracic/lumbar/spine/sacrum, paraspinal soft tissues, proton radiation therapy, photon radiation therapy, radiation applicator plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation
Intervention Description
Administered over a period of 12 weeks.
Intervention Type
Radiation
Intervention Name(s)
Photon Beam Radiation
Intervention Description
Administered over a period of 12 weeks.
Intervention Type
Radiation
Intervention Name(s)
Interoperative radiation
Intervention Description
Radioactive plaque applied at the time of surgical removal of the tumor.
Primary Outcome Measure Information:
Title
To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. DeLaney, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
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