Primary TumorPhase 2NCT01525745
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
A Phase 2 study testing Radiosurgery/SBRT and External Beam Radiation Therapy in people with Primary Tumor and Metastatic Cancer, run by Beth Israel Deaconess Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Tumor, Metastatic Cancer
- What is being tested?
- Radiosurgery/SBRT and External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deacness Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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)
- Conditions
- Primary Tumor, Metastatic Cancer
- Being tested
- Radiosurgery/SBRT, External Beam Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgery/SBRTRadiation
1, 3 or 5 SBRT treatments
External Beam Radiation TherapyRadiation
10 consecutive days of standard radiation
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgery/SBRT | Active comparator | Radiosurgery/SBRT Receives: Radiation: Radiosurgery/SBRT |
| External Beam Radiation Therapy | Active comparator | External Beam Radiation Therapy Receives: Radiation: External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (4)
Duration of Pain Response
Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy
Measured: 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
Measured: 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
Measured: 2 years
Survival
Progrsesion Free and Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Local IRB decision due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary TumorStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Mahadevan, Beth Israel Deaconess Medical Center
- Investigators
- Anand Mahadevan, M.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525745
- Sponsor's protocol ID
- 10-294
- Status last verified
- Jan 2017
- First submitted
- 13 Dec 2011
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis
- ClinicalTrials.gov ID
- NCT01525745
- Acronym / sponsor ID
- 10-294
- Conditions
- Primary Tumor, Metastatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Local IRB decision due to poor accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Posted 29 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery/SBRT | Active comparator | Radiation: Radiosurgery/SBRTRadiosurgery/SBRT |
| External Beam Radiation Therapy | Active comparator | Radiation: External Beam Radiation TherapyExternal Beam Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiosurgery/SBRT1, 3 or 5 SBRT treatments | Radiation | Radiosurgery/SBRT |
| External Beam Radiation Therapy10 consecutive days of standard radiation | Radiation | External Beam Radiation Therapy |
Primary outcome
Pain Control as Measured by NPRS
Time frame: 2 years
Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy
4 secondary outcomes
Duration of Pain Response
Time frame: 2 years
Quality of Life
Time frame: 2 years
Long Term Effects of Image-guided Radiosurgery/SBRT
Time frame: 2 years
Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Mahadevan, M.D. principal investigator
Beth Israel Deaconess Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiosurgery/SBRT and External Beam Radiation Therapy in people with Primary Tumor and Metastatic Cancer, run by Beth Israel Deaconess Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Control as Measured by NPRS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.