Metastatic CancerPhase 1NCT00853528
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
A Phase 1 study testing questionnaire administration, diffusion tensor imaging and functional magnetic resonance imaging in people with Metastatic Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- questionnaire administration, diffusion tensor imaging and functional magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic spinal tumor
- Localized spinal metastasis, defined as one of the following:
- Solitary spinal metastasis
- Two contiguous spinal levels
- No more than 2 adjacent spinal levels involved by a single tumor
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- Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
- Tumor size ≤ 5 cm
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 6 months
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be ambulatory
Who cannot join
- Not pregnant or nursing
- No spinal instability
- No rapid neurological decline
- No bony retropulsions causing neurological abnormalities
- No total paraplegia for > 48 hours
- No psychological issues that would preclude completion of study treatment
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- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
- No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
- No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Cancer Research Center
Boston, Massachusetts, 02118
About this study
Official title: Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
Read the detailed description
OBJECTIVES:
- To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
- To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
- To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.
OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.
Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
- Conditions
- Metastatic Cancer
- Being tested
- questionnaire administration, diffusion tensor imaging, functional magnetic resonance imaging, hypo-fractionated SRS, single-fraction SRS
- Keywords
- spinal cord metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
diffusion tensor imagingProcedure or surgery
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
functional magnetic resonance imagingProcedure or surgery
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter
hypo-fractionated SRSRadiation
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
single-fraction SRSRadiation
two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy
| Study group | Role | What they receive |
|---|---|---|
| Single-fraction radiosurgery; 16 Gray | Experimental | Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging Receives: Other: questionnaire administration; Procedure: diffusion tensor imaging; Procedure: functional magnetic resonance imaging; Radiation: single-fraction SRS |
| Hypo-fractionated radiosurgery; 21 Gray | Experimental | Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray Receives: Other: questionnaire administration; Procedure: diffusion tensor imaging; Procedure: functional magnetic resonance imaging; Radiation: hypo-fractionated SRS |
| Single-fraction radiosurgery; 18 Gray | Experimental | Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging Receives: Other: questionnaire administration; Procedure: diffusion tensor imaging; Procedure: functional magnetic resonance imaging; Radiation: single-fraction SRS |
| Single-fraction radiosurgery; 20 Gray | Experimental | Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging Receives: Other: questionnaire administration; Procedure: diffusion tensor imaging; Procedure: functional magnetic resonance imaging; Radiation: single-fraction SRS |
| Hypo-fractionated radiosurgery; 24 Gray | Experimental | Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray Receives: Other: questionnaire administration; Procedure: diffusion tensor imaging; Procedure: functional magnetic resonance imaging; Radiation: hypo-fractionated SRS |
| Hypo-fractionated radiosurgery; 27 Gray | Experimental | Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray Receives: Other: questionnaire administration; Procedure: diffusion tensor imaging; Procedure: functional magnetic resonance imaging; Radiation: hypo-fractionated SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose - single fraction
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Measured: 6 weeks
Maximum tolerated dose - hypofraction
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Measured: 6 weeks
Secondary outcomes (2)
Assessment of pain
Pain as measured by the Brief Pain Inventory and Roland scale
Measured: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment
Spinal cord response
Spinal cord response as measured by functional MRI
Measured: baseline and then at 6 weeks and 6 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2013
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Boston 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Minh Tam Truong, Boston Medical Center
- Investigators
- Minh-Tam Truong, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853528
- Sponsor's protocol ID
- H-26577
- Other IDs
- W81XWH-07-1-0342, CDR0000635267
- Status last verified
- Jul 2017
- First submitted
- 27 Feb 2009
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
- ClinicalTrials.gov ID
- NCT00853528
- Acronym / sponsor ID
- H-26577
- Conditions
- Metastatic Cancer
- Keywords
- spinal cord metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
Detailed description
OBJECTIVES:
- To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
- To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
- To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.
OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.
Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.
| Arm | Type | Receives |
|---|---|---|
| Single-fraction radiosurgery; 16 Gray | Experimental | Other: questionnaire administration, Procedure: diffusion tensor imaging, Procedure: functional magnetic resonance imaging, Radiation: single-fraction SRSSubjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging |
| Hypo-fractionated radiosurgery; 21 Gray | Experimental | Other: questionnaire administration, Procedure: diffusion tensor imaging, Procedure: functional magnetic resonance imaging, Radiation: hypo-fractionated SRSSubjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray |
| Single-fraction radiosurgery; 18 Gray | Experimental | Other: questionnaire administration, Procedure: diffusion tensor imaging, Procedure: functional magnetic resonance imaging, Radiation: single-fraction SRSSubjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging |
| Single-fraction radiosurgery; 20 Gray | Experimental | Other: questionnaire administration, Procedure: diffusion tensor imaging, Procedure: functional magnetic resonance imaging, Radiation: single-fraction SRSSubjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging |
| Hypo-fractionated radiosurgery; 24 Gray | Experimental | Other: questionnaire administration, Procedure: diffusion tensor imaging, Procedure: functional magnetic resonance imaging, Radiation: hypo-fractionated SRSSubjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray |
| Hypo-fractionated radiosurgery; 27 Gray | Experimental | Other: questionnaire administration, Procedure: diffusion tensor imaging, Procedure: functional magnetic resonance imaging, Radiation: hypo-fractionated SRSSubjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed metastatic spinal tumor
- Karnofsky performance status 60-100%
- Life expectancy ≥ 6 months
- Negative pregnancy test
- Fertile patients must use effective contraception
Key exclusion criteria (11 listed)
- Not pregnant or nursing
- No spinal instability
- No rapid neurological decline
- No bony retropulsions causing neurological abnormalities
- No total paraplegia for > 48 hours
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 |
|---|---|---|
| questionnaire administrationprior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment | Other | Hypo-fractionated radiosurgery; 21 Gray, Hypo-fractionated radiosurgery; 24 Gray, Hypo-fractionated radiosurgery; 27 Gray, Single-fraction radiosurgery; 16 Gray, Single-fraction radiosurgery; 18 Gray, Single-fraction radiosurgery; 20 Gray |
| diffusion tensor imagingprior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy | Procedure or surgery | Hypo-fractionated radiosurgery; 21 Gray, Hypo-fractionated radiosurgery; 24 Gray, Hypo-fractionated radiosurgery; 27 Gray, Single-fraction radiosurgery; 16 Gray, Single-fraction radiosurgery; 18 Gray, Single-fraction radiosurgery; 20 Gray |
| functional magnetic resonance imagingprior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter | Procedure or surgery | Hypo-fractionated radiosurgery; 21 Gray, Hypo-fractionated radiosurgery; 24 Gray, Hypo-fractionated radiosurgery; 27 Gray, Single-fraction radiosurgery; 16 Gray, Single-fraction radiosurgery; 18 Gray, Single-fraction radiosurgery; 20 Gray |
| hypo-fractionated SRStwo to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy | Radiation | Hypo-fractionated radiosurgery; 21 Gray, Hypo-fractionated radiosurgery; 24 Gray, Hypo-fractionated radiosurgery; 27 Gray |
| single-fraction SRStwo to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy | Radiation | Single-fraction radiosurgery; 16 Gray, Single-fraction radiosurgery; 18 Gray, Single-fraction radiosurgery; 20 Gray |
Primary outcome
Maximum tolerated dose - single fraction
Time frame: 6 weeks
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Maximum tolerated dose - hypofraction
Time frame: 6 weeks
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
2 secondary outcomes
Assessment of pain
Time frame: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment
Spinal cord response
Time frame: baseline and then at 6 weeks and 6 months after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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.
Minh-Tam Truong, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing questionnaire administration, diffusion tensor imaging and functional magnetic resonance imaging in people with Metastatic Cancer, run by Boston Medical Center at 1 site 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 14 inclusion and 11 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: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose - single fraction (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 19 Jul 2017.