Neoplasm MetastasisPhase 1/2BLENDNCT02622841

Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases

A Phase 1/2 study testing BLEND in people with Neoplasm Metastasis, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to assess the feasibility and safety of 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: Neoplasm Metastasis
What is being tested?: BLEND
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteNetherlands
Study dates: Jun 2015to Apr 2017
Phase: Phase 1/2
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

Painful metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization
Histologic proof of malignancy
Radiographic evidence of spinal metastases
Karnofsky performance status ≤ 50
Written informed consent

Who cannot join

Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
Previous surgery or radiotherapy to index lesion
stereotactic body radiotherapy cannot be delivered (Bilsky score 2 and 3)
Neurological deficits (ASIA C, B or A)
Partial neurological deficits (ASIA D) with rapid progression (hours to days)
Inability to lie flat on table for stereotactic body radiotherapy

Show all 9Show fewer

Non-ambulatory patients
Patient in hospice or with < 3 months life expectancy
Medically inoperable or patient refused surgery

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University Medical Center Utrecht
Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: First-in-Man Study According to the IDEAL Recommendations

Read the detailed description

Rationale: Sixty-five percent of cancer patients with terminal illness have bone metastases, with debilitating pain as devastating consequence. The spine is the most common location for bone metastases. Spinal cord compression is present in 10% of patients with vertebral metastases and aggravates pain and performance status even further. Standard treatment of unstable vertebral metastases consists of stabilizing surgery, followed by external beam radiotherapy (8 Gy) 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 a long time before radiotherapy induced pain relief is achieved. Scatter artifacts on planning computed tomography images caused by surgical implants prohibit high-resolution imaging and accurate targeting of the lesion. Multiple hospital visits (+/- 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.

Objective: To assess the feasibility and safety of 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.

Study design: Prospective case series (13), first in man study, Phase I and II a study according to the IDEAL recommendations

Study population: All patients, male and female, with impending spinal stability requiring radiation therapy and surgical intervention at the University Medical Center Utrecht

Main study parameters/endpoints: The main outcome of this study is safety of the combined procedure, defined as grade 3 or higher treatment-induced toxicity according to common terminology criteria for adverse events (CTC-AE) 4.0 as a result of the procedure within 60 days after the surgery.

Conditions: Neoplasm Metastasis
Being tested: BLEND
Keywords: First in man, Spinal metastases, Stereotactic bodyradiotherapy, Palliative care, Safety, Surgical stabilisation
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BLENDProcedure or surgery
Stereotactic bodyradiotherapy and surgical stabilization within 48 hours.

Study groups in NCT02622841
Study group	Role	What they receive
BLEND	Experimental	Combination of stereotactic bodyradiotherapy and surgical stabilization within 48 hours for the treatment of unstable spinal metastases. Receives: Procedure: BLEND

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of adverse events
Occurrence of adverse events grade 3/4 according to the common terminology criteria for adverse events (CTCAE) 4.0
Measured: first 90 days post treatment

Secondary outcomes (8)

Pain response
Measurement of pain response to combined therapy according to consensus guidelines
Measured: first 90 days post treatment
Duration of pain relief
Measurement of duration of pain relief
Measured: first 90 days post treatment
Rapidity of pain relief
Measurement of rapidity of pain relief
Measured: first 90 days post treatment
Hospital stay
Measurement of length of hospital stay
Measured: first 90 days post treatment
Early mortality
Measurement of 30 days mortality
Measured: First 30 days post treatment
Neurological status
Measurement of neurological deterioration
Measured: First 90 days post treatment
Quality of life
Evaluation of quality of life
Measured: first 90 days post treatment
Survival
Overall survival
Measured: Time from inclusion until date of death from any cause assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Apr 2017

First posted7 Dec 2015 (estimated)
Study startJun 2015
Primary completionApr 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neoplasm MetastasisStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02622841
Sponsor's protocol ID: NL51405.041.15
Acronym: BLEND
Status last verified: May 2017
First submitted: 17 Sep 2015
Last updated: 8 May 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplasm Metastasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2017. 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: First-in-Man Study According to the IDEAL Recommendations
ClinicalTrials.gov ID: NCT02622841
Acronym / sponsor ID: BLEND / NL51405.041.15
Conditions: Neoplasm Metastasis
Keywords: First in man, Spinal metastases, Stereotactic bodyradiotherapy, Palliative care, Safety, Surgical stabilisation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: UMC UtrechtUniversity, hospital or other
Study start: Jun 2015 (actual)
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 7 Dec 2015 (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.

Detailed description

Study design: Prospective case series (13), first in man study, Phase I and II a study according to the IDEAL recommendations

Study population: All patients, male and female, with impending spinal stability requiring radiation therapy and surgical intervention at the University Medical Center Utrecht

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BLEND	Experimental	Procedure: BLENDCombination of stereotactic bodyradiotherapy and surgical stabilization within 48 hours for the treatment of unstable spinal metastases.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Painful metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization
Histologic proof of malignancy
Radiographic evidence of spinal metastases
Karnofsky performance status ≤ 50
Written informed consent

Key exclusion criteria (9 listed)

Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
Previous surgery or radiotherapy to index lesion
stereotactic body radiotherapy cannot be delivered (Bilsky score 2 and 3)
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
BLENDStereotactic bodyradiotherapy and surgical stabilization within 48 hours.	Procedure or surgery	BLEND

Primary outcome

Occurrence of adverse events
Time frame: first 90 days post treatment
Occurrence of adverse events grade 3/4 according to the common terminology criteria for adverse events (CTCAE) 4.0

8 secondary outcomes

Pain response
Time frame: first 90 days post treatment
Duration of pain relief
Time frame: first 90 days post treatment
Rapidity of pain relief
Time frame: first 90 days post treatment
Hospital stay
Time frame: first 90 days post treatment
Early mortality
Time frame: First 30 days post treatment
Neurological status
Time frame: First 90 days post treatment
Quality of life
Time frame: first 90 days post treatment
Survival
Time frame: Time from inclusion until date of death from any cause assessed up to 100 months

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 8 May 2017.

Related trials for Neoplasm Metastasis

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Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
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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 Phase 1/2 study testing BLEND in people with 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 5 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: finished, as of the sponsor's last update on 8 May 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 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.

What does this combined 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.

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?

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?

Occurrence of adverse events (time frame: first 90 days post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622841.

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 8 May 2017.