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

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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

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:

Administered over a period of 12 weeks.

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

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:	February 19, 2013
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, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013