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

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.

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 Overview

• Status: Terminated
• Conditions: Solid Tumors; Spine Metastasis
• Intervention / Treatment: Device: Conventional vertebroplasty; Device: Kyphoplasty

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre LEON BERARD
  • Saint-Étienne, France, 42270
    • Hopital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate for each strategy	The success rate will be calculated with the proportion of patients without cement leakage	3 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pain will be assessed using a Visual Analogic Scale	The day after the procedure
Analgesic properties of the strategies at 21 days	Pain will be assessed using a Visual Analogic Scale	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	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	Through study completion
Type of cement leakage (vascular versus cortical localisation)	Location will be described as vascular or cortical using the imaging assessments	3 months after the procedure
Size of cement leakage	Size will be described as significant or not significant as per investigator judgement	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	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	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	3 months after the procedure
Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale		3 months after the procedure

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Amine BOUHAMAMA, MD, Centre LEON BERARD

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Solid tumors; Spine metastasis; Vertebroplasty; kyphoplasty; randomization
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: ET14000050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No