Spinal NeoplasmsBLEND-IINCT05060653
Stereotactic Body Radiotherapy Followed by Surgical Stabilization in Spinal Metastases
A study testing SBRT followed by surgical stabilization within 24-48 hours in people with Spinal Neoplasms and Neoplasm Metastasis, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The aim of this study is to assess pain response after combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Neoplasms, Neoplasm Metastasis, Radiosurgery
- What is being tested?
- SBRT followed by surgical stabilization within 24-48 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2022to Nov 2023
- Phase
- Interventional
- 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
- Participation in PRESENT cohort
- Painful radiosensitive metastases from solid tumors in the cervical, thoracic or lumbar spine needing surgical stabilization
- Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt
- Radiographic evidence of spinal metastases
- Fit for (radio)surgery
- Age > 18 years at the time of given informed consent in the PRESENT cohort.
- Written informed consent
Who cannot join
- SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
- Surgery cannot be performed, e.g. in patients with multiple spinal metastases that cannot be bridged
- Previous surgery or radiotherapy to index lesion
- Neurological deficits (ASIA C, B or A)
- Partial neurological deficits (ASIA D) with rapid progression (hours to days)
- Non-ambulatory patients
Show all 9Show fewer
- Patient in hospice or with < 3 months life expectancy
- Medically inoperable or patient refused surgery
- Radiosensitizing systemic treatment that cannot reasonably be stopped (for example immunotherapy and EGFR inhibitors)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: Cohort Study According to the IDEAL Recommendations
The aim of this study is to assess pain response after combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.
Read the detailed description
Rationale Sixty-five percent of cancer patients with terminal illness have bone metastases, with debilitating pain often as the severe consequence. The spine is the most common location for bone metastases. Standard treatment of unstable vertebral metastases consists of stabilizing surgery, followed by external beam radiotherapy after two weeks. Although this approach is effective in 60-70% of patients, it is has several downsides. Firstly, because of the two weeks interval between surgery and external beam radiotherapy, necessary for sufficient wound healing, it takes time before radiotherapy-induced pain relief is achieved. Moreover, the surgical implants used cause scatter artifacts on planning computed tomography images which prohibits high-resolution imaging and accurate targeting of the lesion. Multiple hospital visits (ranging from 1 to 10) are needed for administration of external beam irradiation, and in about 30-40% of patients no adequate pain response is achieved. An alternative treatment strategy, which would lead to faster pain relief in a higher proportion of patients with less hospital visits, would be highly desirable from the patient's perspective. Secondly, this strategy delays the start of systemic therapy.
Objective The main outcome of this study is pain response 4 weeks after start of the treatment.
Study design Prospective cohort study nested within the PRESENT cohort being a phase 2b study according to the IDEAL recommendations
Study population All patients, male and female, with impending spinal instability requiring surgical intervention and radiotherapy at the University Medical Center Utrecht
Intervention The combined treatment of stereotactic body radiotherapy and pedicle screw fixation in a 24 to 48-hour window for the treatment of painful unstable metastases of the cervical, thoracic and/or lumbar spine.
Main study parameters/endpoints The main outcome of this study is pain response after 4 weeks
Nature and extent of the burden and risks associated with participation, benefit and group relatedness In the preceding BLEND First-in-man study, the investigators have observed no Serious Adverse Events after a median follow-up of 13 months demonstrating the safety and feasibility of this approach.
- Conditions
- Spinal Neoplasms, Neoplasm Metastasis, Radiosurgery, Surgery
- Being tested
- SBRT followed by surgical stabilization within 24-48 hours
- Medical subject headings
- Spinal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT followed by surgical stabilization within 24-48 hoursOther
In a first step, patients will undergo SBRT with active sparing of the surgical site. Patients will receive high dose, single to few fractions radiotherapy consisting of a boost to the metastases exclusively. The bony compartment containing the metastatic lesion will receive an elective dose in order to treat subclinical disease. Treatment planning is performed on the pre-treatment CT and MRI data in radiotherapy position that are mutually registered to yield information on all relevant structures for planning. Dose constraints are set for the organ at risks based on institution specific guidelines. All patients will be treated with on online position verification protocol based on institution specific guidelines. Hereafter, surgical intervention will be performed to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| SBRT followed by surgical stabilization within 48 hours | Experimental | SBRT and surgical stabilization will be performed within a 24 to 48-hour time window instead of today's standard of care of two weeks between surgical stabilization and conventional radiotherapy. Receives: Other: SBRT followed by surgical stabilization within 24-48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
Pain response is defined as a decrease in initial worst pain score by at least 2 points on a Numeric Rating Scale (NRS) of 10 at the treated site, without increase in analgesic use, or an analgesic decrease of at least 25% without an increase in pain score
Measured: 4 weeks
Secondary outcomes (6)
Duration of pain relief
Duration of pain relief, as measured by the Brief Pain Inventory (BPI)
Measured: Through hospital stay, an average of 3 days
Length of hospital stay
Length of hospital stay in days
Measured: Through hospital stay, an average of 3 days
30-day mortality
Mortality after 30 days
Measured: 30 days
Neurological status
American Spinal Injury Association (ASIA) scale as measured by physical examination of neurologists or trained ASIA physician
Measured: Through hospital stay, an average of 3 days
Neurological deterioration
Defined as a deterioration on the American Spinal Injury Association (ASIA) scale of more than one level
Measured: Through hospital stay, an average of 3 days
Adverse events
Adverse events will be scored using a SAVES form
Measured: Through hospital stay, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Alternative study was set up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.J. Verlaan, UMC Utrecht
- Investigators
- Jorrit-Jan Verlaan, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060653
- Sponsor's protocol ID
- NL76750.041.21
- Acronym
- BLEND-II
- Status last verified
- May 2023
- First submitted
- 6 Aug 2021
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be shared when requested through the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: Cohort Study According to the IDEAL Recommendations
- ClinicalTrials.gov ID
- NCT05060653
- Acronym / sponsor ID
- BLEND-II / NL76750.041.21
- Conditions
- Spinal Neoplasms, Neoplasm Metastasis, Radiosurgery, Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Alternative study was set up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 29 Sep 2021 (actual)
- 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.
The aim of this study is to assess pain response after combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.
Detailed description
Rationale Sixty-five percent of cancer patients with terminal illness have bone metastases, with debilitating pain often as the severe consequence. The spine is the most common location for bone metastases. Standard treatment of unstable vertebral metastases consists of stabilizing surgery, followed by external beam radiotherapy after two weeks. Although this approach is effective in 60-70% of patients, it is has several downsides. Firstly, because of the two weeks interval between surgery and external beam radiotherapy, necessary for sufficient wound healing, it takes time before radiotherapy-induced pain relief is achieved. Moreover, the surgical implants used cause scatter artifacts on planning computed tomography images which prohibits high-resolution imaging and accurate targeting of the lesion. Multiple hospital visits (ranging from 1 to 10) are needed for administration of external beam irradiation, and in about 30-40% of patients no adequate pain response is achieved. An alternative treatment strategy, which would lead to faster pain relief in a higher proportion of patients with less hospital visits, would be highly desirable from the patient's perspective. Secondly, this strategy delays the start of systemic therapy.
Objective The main outcome of this study is pain response 4 weeks after start of the treatment.
Study design Prospective cohort study nested within the PRESENT cohort being a phase 2b study according to the IDEAL recommendations
Study population All patients, male and female, with impending spinal instability requiring surgical intervention and radiotherapy at the University Medical Center Utrecht
Intervention The combined treatment of stereotactic body radiotherapy and pedicle screw fixation in a 24 to 48-hour window for the treatment of painful unstable metastases of the cervical, thoracic and/or lumbar spine.
Main study parameters/endpoints The main outcome of this study is pain response after 4 weeks
Nature and extent of the burden and risks associated with participation, benefit and group relatedness In the preceding BLEND First-in-man study, the investigators have observed no Serious Adverse Events after a median follow-up of 13 months demonstrating the safety and feasibility of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT followed by surgical stabilization within 48 hours | Experimental | Other: SBRT followed by surgical stabilization within 24-48 hoursSBRT and surgical stabilization will be performed within a 24 to 48-hour time window instead of today's standard of care of two weeks between surgical stabilization and conventional radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participation in PRESENT cohort
- Painful radiosensitive metastases from solid tumors in the cervical, thoracic or lumbar spine needing surgical stabilization
- Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt
- Radiographic evidence of spinal metastases
- Fit for (radio)surgery
Key exclusion criteria (9 listed)
- SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
- Surgery cannot be performed, e.g. in patients with multiple spinal metastases that cannot be bridged
- Previous surgery or radiotherapy to index lesion
- Neurological deficits (ASIA C, B or A)
- Partial neurological deficits (ASIA D) with rapid progression (hours to days)
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 |
|---|---|---|
| SBRT followed by surgical stabilization within 24-48 hoursIn a first step, patients will undergo SBRT with active sparing of the surgical site. Patients will receive high dose, single to few fractions radiotherapy consisting of a boost to the metastases exclusively. The bony compartment containing the metastatic lesion will receive an elective dose in order to treat subclinical disease. Treatment planning is performed on the pre-treatment CT and MRI data in radiotherapy position that are mutually registered to yield information on all relevant structures for planning. Dose constraints are set for the organ at risks based on institution specific guidelines. All patients will be treated with on online position verification protocol based on institution specific guidelines. Hereafter, surgical intervention will be performed to the standard of care. | Other | SBRT followed by surgical stabilization within 48 hours |
Primary outcome
Pain response
Time frame: 4 weeks
Pain response is defined as a decrease in initial worst pain score by at least 2 points on a Numeric Rating Scale (NRS) of 10 at the treated site, without increase in analgesic use, or an analgesic decrease of at least 25% without an increase in pain score
6 secondary outcomes
Duration of pain relief
Time frame: Through hospital stay, an average of 3 days
Length of hospital stay
Time frame: Through hospital stay, an average of 3 days
30-day mortality
Time frame: 30 days
Neurological status
Time frame: Through hospital stay, an average of 3 days
Neurological deterioration
Time frame: Through hospital stay, an average of 3 days
Adverse events
Time frame: Through hospital stay, an average of 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No. IPD may be shared when requested through the principal investigator
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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.
Jorrit-Jan Verlaan, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT followed by surgical stabilization within 24-48 hours in people with Spinal Neoplasms and Neoplasm Metastasis, run by UMC Utrecht at 1 site in Netherlands.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 18 May 2023. 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 Netherlands. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 response (time frame: 4 weeks). 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 18 May 2023.