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

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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment.

Condition

Mesenchymal Tumor

Intervention

Proton Beam Radiation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

50

Start Date

May 1999

Completion Date

March 2016

Primary Completion Date

March 2005

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas F. DeLaney, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00592345

Organization ID

97-502


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

Thomas F. DeLaney, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

February 2017