Solid Tumors, Spine Metastasis
Conditions
Keywords
Solid tumors, Spine metastasis, Vertebroplasty, kyphoplasty, randomization
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.
Interventions
DEVICEKyphoplasty
Placement and inflation of balloon prior to cement injection
DEVICEConventional vertebroplasty
Conventional vertebroplasty
Sponsors
Centre Leon Berard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate for each strategy | 3 months after the procedure | The success rate will be calculated with the proportion of patients without cement leakage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height of the targeted vertebrae | 3 months after the procedure | — |
| Height of the patient | 3 months after the procedure | — |
| Kyphotic angle | 3 months after the procedure | — |
| Analgesic properties of the strategies the day after the procedure | The day after the procedure | Pain will be assessed using a Visual Analogic Scale |
| Analgesic properties of the strategies at the end of the study | 3 months after the procedure | Pain will be assessed using a Visual Analogic Scale |
| Tolerance profile of the strategies | Through study completion | Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4 |
| Analgesic properties of the strategies at 21 days | 21 days after the procedure | Pain will be assessed using a Visual Analogic Scale |
| Size of cement leakage | 3 months after the procedure | Size will be described as significant or not significant as per investigator judgement |
| Symptoms associated with cement leakage | 3 months after the procedure | 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 | 21 days after procedure | Quality of Life will be assessed with the Dallas questionnaire for spinal pain |
| Quality of Life in both arms at the end oh study | 3 months after the procedure | 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 | 3 months after the procedure | — |
| Type of cement leakage (vascular versus cortical localisation) | 3 months after the procedure | Location will be described as vascular or cortical using the imaging assessments |
Countries
France
Outcome results
None listed