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

NCT00592345 | Completed Phase 1 DMC

• 1 other identifier: 97-502
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenchymal Tumor

Keywords

sarcoma of the thoracic/lumbar/spine/sacrum; paraspinal soft tissues; proton radiation therapy; photon radiation therapy; radiation applicator plaque

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (1)

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

  3 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Declines radical surgery
• No prior radiation treatment to the affected spine region

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Thomas F. DeLaney, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: May 1, 1999
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

US (1)