Back to resultsA Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases (KYPHO-01)
Primary Purpose
Solid Tumors, Spine Metastasis
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Kyphoplasty
Conventional vertebroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors focused on measuring Solid tumors, Spine metastasis, Vertebroplasty, kyphoplasty, randomization
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Centre Léon Bérard
- Hopital Nord
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional vertebroplasty
Kyphoplasty
Arm Description
Conventional vertebroplasty (device's trade at the discretion of the investigator)
Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)
Outcomes
Primary Outcome Measures
Success rate for each strategy
The success rate will be calculated with the proportion of patients without cement leakage
Secondary Outcome Measures
Height of the targeted vertebrae
Height of the patient
Kyphotic angle
Analgesic properties of the strategies the day after the procedure
Pain will be assessed using a Visual Analogic Scale
Analgesic properties of the strategies at 21 days
Pain will be assessed using a Visual Analogic Scale
Analgesic properties of the strategies at the end of the study
Pain will be assessed using a Visual Analogic Scale
Tolerance profile of the strategies
Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4
Type of cement leakage (vascular versus cortical localisation)
Location will be described as vascular or cortical using the imaging assessments
Size of cement leakage
Size will be described as significant or not significant as per investigator judgement
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
Quality of Life in both arms at Day 21
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Quality of Life in both arms at the end oh study
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02700308
Brief Title
A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
Acronym
KYPHO-01
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
DECISION OF THE SPONSOR AND THE COORDINATING INVESTIGATOR DUE TO RECRUITMENT DIFFICULTIES AND CHANGES IN INTERVENTIONAL RADIOLOGY PRACTICES
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Spine Metastasis
Keywords
Solid tumors, Spine metastasis, Vertebroplasty, kyphoplasty, randomization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional vertebroplasty
Arm Type
Active Comparator
Arm Description
Conventional vertebroplasty (device's trade at the discretion of the investigator)
Arm Title
Kyphoplasty
Arm Type
Experimental
Arm Description
Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)
Intervention Type
Device
Intervention Name(s)
Kyphoplasty
Other Intervention Name(s)
Balloon kyphoplasty
Intervention Description
Placement and inflation of balloon prior to cement injection
Intervention Type
Device
Intervention Name(s)
Conventional vertebroplasty
Other Intervention Name(s)
Vertebroplasty
Intervention Description
Conventional vertebroplasty
Primary Outcome Measure Information:
Title
Success rate for each strategy
Description
The success rate will be calculated with the proportion of patients without cement leakage
Time Frame
3 months after the procedure
Secondary Outcome Measure Information:
Title
Height of the targeted vertebrae
Time Frame
3 months after the procedure
Title
Height of the patient
Time Frame
3 months after the procedure
Title
Kyphotic angle
Time Frame
3 months after the procedure
Title
Analgesic properties of the strategies the day after the procedure
Description
Pain will be assessed using a Visual Analogic Scale
Time Frame
The day after the procedure
Title
Analgesic properties of the strategies at 21 days
Description
Pain will be assessed using a Visual Analogic Scale
Time Frame
21 days after the procedure
Title
Analgesic properties of the strategies at the end of the study
Description
Pain will be assessed using a Visual Analogic Scale
Time Frame
3 months after the procedure
Title
Tolerance profile of the strategies
Description
Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4
Time Frame
Through study completion
Title
Type of cement leakage (vascular versus cortical localisation)
Description
Location will be described as vascular or cortical using the imaging assessments
Time Frame
3 months after the procedure
Title
Size of cement leakage
Description
Size will be described as significant or not significant as per investigator judgement
Time Frame
3 months after the procedure
Title
Symptoms associated with cement leakage
Description
Symptoms associated with cement leakage will be tolerance events that are stated by the investigator as related to a cement leakage
Time Frame
3 months after the procedure
Title
Quality of Life in both arms at Day 21
Description
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Time Frame
21 days after procedure
Title
Quality of Life in both arms at the end oh study
Description
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Time Frame
3 months after the procedure
Title
Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale
Time Frame
3 months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amine BOUHAMAMA, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Nord
City
Saint-Étienne
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
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