Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis

NCT01525745 | Terminated Phase 2 Results DMC

• 1 other identifier: 10-294
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine how effective SBRT is compared to traditional radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is delivered at a higher dose for a shorter period of time when compared to standard radiation therapy and the aim is to see if there will be an improvement both in pain control and your cancer It is not known whether SBRT is better or worse than current standard therapy. If you are selected to receive the experimental treatment in this research study, SBRT uses highly focused x-rays that deliver a single high dose to a specific area of the spine compared to conventional standard radiation over a period of 10 days which has been the standard proven treatment to help your condition. The investigators will also determine which treatment provides the most rapid pain relief with the least side effects. It is possible that SBRT may not be better or could be more toxic. The investigators will conduct quality of life assessments and pain scale index to assess how you are feeling once you have had the intervention.

Conditions

Primary Tumor; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Pain Control as Measured by NPRS

  Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy

  2 years

Secondary Outcomes (4)

• Duration of Pain Response

  2 years

• Quality of Life

  2 years

• Long Term Effects of Image-guided Radiosurgery/SBRT

  2 years

• Survival

  2 years

Study Arms (2)

Radiosurgery/SBRT

ACTIVE COMPARATOR

Radiosurgery/SBRT

Radiation: Radiosurgery/SBRT

External Beam Radiation Therapy

ACTIVE COMPARATOR

External Beam Radiation Therapy

Radiation: External Beam Radiation Therapy

Interventions

Radiosurgery/SBRT RADIATION

1, 3 or 5 SBRT treatments

Radiosurgery/SBRT

External Beam Radiation Therapy RADIATION

10 consecutive days of standard radiation

External Beam Radiation Therapy

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary tumor or metastatic cancer with radiological diagnosis of spine metastasis
• The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study
• Zubrod Performance Status 0-2
• History/physical examination within 2 weeks prior to registration
• Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement
• Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of \>5 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
• Neurological examination within 1 week prior to registration to rule out rapid neurologic decline

You may not qualify if:

• Histology of myeloma, lymphoma or germ cell tumors.
• Non-ambulatory patients
• Spine instability due to a compression fracture
• \> 50% loss of vertebral body height
• Frank spinal cord displacement or epidural involvement with\> 25% encirclement of cord or \>25% spinal canal involvement.
• Prior radiation to the index spine
• Patients for whom an MRI of the spine is medically contraindicated
• Uncontrolled intercurrent illness

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (3)

Beth Israel Deacness Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anand Mahadevan, MD
• Organization: Beth Israel Deaconess Medical Center

amahadev@bidmc.harvard.edu

617-667-2345

Study Officials

• Anand Mahadevan, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 6, 2017
• Results First Posted: August 29, 2016

Record last verified: 2017-01

Locations

US (3)