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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592345
First received: December 28, 2007
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Mesenchymal Tumor
Radiation: Proton Beam Radiation
Radiation: Photon Beam Radiation
Radiation: Interoperative radiation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Enrollment: 50
Study Start Date: May 1999
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592345

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Tom DeLaney, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592345     History of Changes
Other Study ID Numbers: 97-502
Study First Received: December 28, 2007
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on November 27, 2014