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

Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Cancer; Primary Tumor
• Intervention / Treatment: Radiation: Radiosurgery/SBRT; Radiation: External Beam Radiation Therapy

Detailed Description

Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in.

You will have a 2 to 1 chance of being placed in the SBRT to standard radiation group. Since SBRT is the newer treatment being tested, we would like to include more patients in this group.

Treatment Procedures:

SBRT: You may receive one, three or five SBRT treatments depending on the extent of your cancer. During each treatment you will be assessed by a nurse and a physician for a physical and neurological assessment. The treatment itself would last approximately I hour where you will be lying on a treatment table. Prior to each treatment you will have a physical and neurological assessment by a physician. Standard Radiation: You will receive ten consecutive working days of standard radiation. While each treatment lasts five to ten minutes, the entire visit may last up to thirty minutes. During the treatment you will be lying on a treatment table. Once per week you will have a physical and neurological assessment by your treating physician After the final treatment of the study therapy: We would like to keep track of your medical condition for at least 12 months after you receive treatment. We would like to do this by having you come in to the clinic at months 1, 3, 6, 12 and 24 months after treatment*. At these visits we will be looking for the same information as during the screening time frame. This includes:

• A history and physical from you
• A Performance Status of how you are able to carry on with your usual activities.
• A Pain scale questionnaire called the Numerical Rating Pain Scale(NRPS) that asks to explain your pain symptoms on a 0-10 scale
• 3 Quality Of Life (QOL) Assessments described below:
• Functional Assessment of Cancer Therapy-General (FACT-G)
• The Brief Pain Inventory (BPI)
• The EuroQOL (EQ-5D)
• An assessment of your tumor by MRI (Magnetic Resonance Imaging)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deacness Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiosurgery/SBRT	Radiation: Radiosurgery/SBRT; 1, 3 or 5 SBRT treatments
Active Comparator: External Beam Radiation Therapy	Radiation: External Beam Radiation Therapy; 10 consecutive days of standard radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Pain Response	Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy	2 years
Quality of Life	Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D	2 years
Long Term Effects of Image-guided Radiosurgery/SBRT	Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord	2 years
Survival	Progrsesion Free and Overall Survival	2 years

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Anand Mahadevan, M.D., Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 10-294