Clinical trial NCT02700308: A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumors
Spine Metastasis
Keywords: Solid tumors
Spine metastasis
Vertebroplasty
kyphoplasty
randomization
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Success rate for each strategy
timeFrame: 3 months after the procedure
Secondary outcomes:
measure: Height of the targeted vertebrae
timeFrame: 3 months after the procedure
measure: Height of the patient
timeFrame: 3 months after the procedure
measure: Kyphotic angle
timeFrame: 3 months after the procedure
measure: Analgesic properties of the strategies the day after the procedure
timeFrame: The day after the procedure
measure: Analgesic properties of the strategies at 21 days
timeFrame: 21 days after the procedure
measure: Analgesic properties of the strategies at the end of the study
timeFrame: 3 months after the procedure
measure: Tolerance profile of the strategies
timeFrame: Through study completion
measure: Type of cement leakage (vascular versus cortical localisation)
timeFrame: 3 months after the procedure
measure: Size of cement leakage
timeFrame: 3 months after the procedure
measure: Symptoms associated with cement leakage
timeFrame: 3 months after the procedure
measure: Quality of Life in both arms at Day 21
timeFrame: 21 days after procedure
measure: Quality of Life in both arms at the end oh study
timeFrame: 3 months after the procedure
measure: Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale
timeFrame: 3 months after the procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
city: Saint-Étienne
country: France
facility: Hopital Nord
Study officials:
affiliation: Centre Leon Berard
name: Amine BOUHAMAMA, MD
role: PRINCIPAL_INVESTIGATOR
References: