Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
Primary Purpose
Primary Tumor, Metastatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiosurgery/SBRT
External Beam Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Tumor
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deacness Medical Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Radiosurgery/SBRT
External Beam Radiation Therapy
Arm Description
Radiosurgery/SBRT
External Beam Radiation Therapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of Pain Response
Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy
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
Long Term Effects of Image-guided Radiosurgery/SBRT
Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord
Survival
Progrsesion Free and Overall Survival
Full Information
NCT ID
NCT01525745
First Posted
December 13, 2011
Last Updated
January 23, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01525745
Brief Title
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
Official Title
Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Local IRB decision due to poor accrual
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Tumor, Metastatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiosurgery/SBRT
Arm Type
Active Comparator
Arm Description
Radiosurgery/SBRT
Arm Title
External Beam Radiation Therapy
Arm Type
Active Comparator
Arm Description
External Beam Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery/SBRT
Intervention Description
1, 3 or 5 SBRT treatments
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Intervention Description
10 consecutive days of standard radiation
Primary Outcome Measure Information:
Title
Pain Control as Measured by NPRS
Description
Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of Pain Response
Description
Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy
Time Frame
2 years
Title
Quality of Life
Description
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
Time Frame
2 years
Title
Long Term Effects of Image-guided Radiosurgery/SBRT
Description
Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord
Time Frame
2 years
Title
Survival
Description
Progrsesion Free and Overall Survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Mahadevan, M.D.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deacness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
We'll reach out to this number within 24 hrs