KYPHO-01: A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

Sponsor

Centre Leon Berard (Other)

Overall Status

Terminated

CT.gov ID

NCT02700308

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

15.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors Spine Metastasis	Device: Kyphoplasty Device: Conventional vertebroplasty	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional vertebroplasty Conventional vertebroplasty (device's trade at the discretion of the investigator)	Device: Conventional vertebroplasty Conventional vertebroplasty Other Names: Vertebroplasty
Experimental: Kyphoplasty Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)	Device: Kyphoplasty Placement and inflation of balloon prior to cement injection Other Names: Balloon kyphoplasty

Arm

Intervention/Treatment

Active Comparator: Conventional vertebroplasty

Conventional vertebroplasty (device's trade at the discretion of the investigator)

Device: Conventional vertebroplasty

Conventional vertebroplasty

Other Names:

Vertebroplasty

Experimental: Kyphoplasty

Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)

Device: Kyphoplasty

Placement and inflation of balloon prior to cement injection

Other Names:

Balloon kyphoplasty

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 21 days [21 days 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
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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.