Solid TumorsPhase 2KYPHO-01NCT02700308
A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
A Phase 2 study testing Kyphoplasty and Conventional vertebroplasty in people with Solid Tumors and Spine Metastasis, run by Centre Leon Berard at 2 sites in France.
Trial summary
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Spine Metastasis
- What is being tested?
- Kyphoplasty and Conventional vertebroplasty
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2016to Dec 2020
- Phase
- Phase 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
- Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
- 2 metastatic sites or more;
- Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
- Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
- Pain equal or greater than 4/10 at Visual Analogic Scale
- Unstable vertebrae (SINS score equal or greater than 7;
- Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2
Who cannot join
- Contraindication to vertebroplasty, including contraindication to cement use;
- Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
- Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
- Neurological deficit due to medullar or radicular compression;
- Participation to another clinical trial with an analgesic intent.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.
The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.
Read more
Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.
In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.
To date, no data from randomized study are available in the population of cancer patients.
- Conditions
- Solid Tumors, Spine Metastasis
- Being tested
- Kyphoplasty, Conventional vertebroplasty
- Keywords
- Solid tumors, Spine metastasis, Vertebroplasty, kyphoplasty, randomization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KyphoplastyDevice
Also called Balloon kyphoplasty
Placement and inflation of balloon prior to cement injection
Conventional vertebroplastyDevice
Also called Vertebroplasty
Conventional vertebroplasty
| Study group | Role | What they receive |
|---|---|---|
| Conventional vertebroplasty | Active comparator | Conventional vertebroplasty (device's trade at the discretion of the investigator) Receives: Device: Conventional vertebroplasty |
| Kyphoplasty | Experimental | Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator) Receives: Device: Kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate for each strategy
The success rate will be calculated with the proportion of patients without cement leakage
Measured: 3 months after the procedure
Secondary outcomes (13)
Height of the targeted vertebrae
Measured: 3 months after the procedure
Height of the patient
Measured: 3 months after the procedure
Kyphotic angle
Measured: 3 months after the procedure
Analgesic properties of the strategies the day after the procedure
Pain will be assessed using a Visual Analogic Scale
Measured: The day after the procedure
Analgesic properties of the strategies at 21 days
Pain will be assessed using a Visual Analogic Scale
Measured: 21 days after the procedure
Analgesic properties of the strategies at the end of the study
Pain will be assessed using a Visual Analogic Scale
Measured: 3 months after the procedure
Tolerance profile of the strategies
Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4
Measured: Through study completion
Type of cement leakage (vascular versus cortical localisation)
Location will be described as vascular or cortical using the imaging assessments
Measured: 3 months after the procedure
Size of cement leakage
Size will be described as significant or not significant as per investigator judgement
Measured: 3 months after the procedure
Symptoms associated with cement leakage
Symptoms associated with cement leakage will be tolerance events that are stated by the investigator as related to a cement leakage
Measured: 3 months after the procedure
Quality of Life in both arms at Day 21
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Measured: 21 days after procedure
Quality of Life in both arms at the end oh study
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Measured: 3 months after the procedure
Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: DECISION OF THE SPONSOR AND THE COORDINATING INVESTIGATOR DUE TO RECRUITMENT DIFFICULTIES AND CHANGES IN INTERVENTIONAL RADIOLOGY PRACTICES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amine BOUHAMAMA, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700308
- Sponsor's protocol ID
- ET14000050
- Acronym
- KYPHO-01
- Status last verified
- Jul 2022
- First submitted
- 27 Oct 2015
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT02700308
- Acronym / sponsor ID
- KYPHO-01 / ET14000050
- Conditions
- Solid Tumors, Spine Metastasis
- Keywords
- Solid tumors, Spine metastasis, Vertebroplasty, kyphoplasty, randomization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DECISION OF THE SPONSOR AND THE COORDINATING INVESTIGATOR DUE TO RECRUITMENT DIFFICULTIES AND CHANGES IN INTERVENTIONAL RADIOLOGY PRACTICES
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Mar 2016 (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.
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.
The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.
Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.
In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.
To date, no data from randomized study are available in the population of cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional vertebroplasty | Active comparator | Device: Conventional vertebroplastyConventional vertebroplasty (device's trade at the discretion of the investigator) |
| Kyphoplasty | Experimental | Device: KyphoplastyVertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
- 2 metastatic sites or more;
- Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
- Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
- Pain equal or greater than 4/10 at Visual Analogic Scale
Key exclusion criteria (5 listed)
- Contraindication to vertebroplasty, including contraindication to cement use;
- Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
- Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
- Neurological deficit due to medullar or radicular compression;
- Participation to another clinical trial with an analgesic intent.
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 |
|---|---|---|
| KyphoplastyAlso: Balloon kyphoplastyPlacement and inflation of balloon prior to cement injection | Device | Kyphoplasty |
| Conventional vertebroplastyAlso: VertebroplastyConventional vertebroplasty | Device | Conventional vertebroplasty |
Primary outcome
Success rate for each strategy
Time frame: 3 months after the procedure
The success rate will be calculated with the proportion of patients without cement leakage
13 secondary outcomes
Height of the targeted vertebrae
Time frame: 3 months after the procedure
Height of the patient
Time frame: 3 months after the procedure
Kyphotic angle
Time frame: 3 months after the procedure
Analgesic properties of the strategies the day after the procedure
Time frame: The day after the procedure
Analgesic properties of the strategies at 21 days
Time frame: 21 days after the procedure
Analgesic properties of the strategies at the end of the study
Time frame: 3 months after the procedure
Tolerance profile of the strategies
Time frame: Through study completion
Type of cement leakage (vascular versus cortical localisation)
Time frame: 3 months after the procedure
Size of cement leakage
Time frame: 3 months after the procedure
Symptoms associated with cement leakage
Time frame: 3 months after the procedure
Quality of Life in both arms at Day 21
Time frame: 21 days after procedure
Quality of Life in both arms at the end oh study
Time frame: 3 months after the procedure
Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale
Time frame: 3 months after the procedure
Results and safety
The study was stopped early (reason given: DECISION OF THE SPONSOR AND THE COORDINATING INVESTIGATOR DUE TO RECRUITMENT DIFFICULTIES AND CHANGES IN INTERVENTIONAL RADIOLOGY PRACTICES). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Amine BOUHAMAMA, MD principal investigator
Centre Leon Berard
2 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 Kyphoplasty and Conventional vertebroplasty in people with Solid Tumors and Spine Metastasis, run by Centre Leon Berard at 2 sites in France.
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 5 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was stopped early (reason given: DECISION OF THE SPONSOR AND THE COORDINATING INVESTIGATOR DUE TO RECRUITMENT DIFFICULTIES AND CHANGES IN INTERVENTIONAL RADIOLOGY PRACTICES). Results are not available in the source record.
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?
Success rate for each strategy (time frame: 3 months after the procedure). 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 28 Jul 2022.