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Completed

NCT Number: NCT00592345

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton beam radiation

Radiation

Administered over a period of 12 weeks.

Photon Beam Radiation

Radiation

Administered over a period of 12 weeks.

Interoperative radiation

Radiation

Radioactive plaque applied at the time of surgical removal of the tumor.

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
1999
Primary completion
2005
Study completion
2016
First posted
Jan 14, 2008
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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