A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

Solid Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02700308
• Other study ID #: ET14000050
• Status: Terminated
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: December 2020

Study information

• Verified date: July 2022
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Solid Tumors
• Spine Metastasis

Intervention

Device:
• Kyphoplasty
Placement and inflation of balloon prior to cement injection
• Conventional vertebroplasty
Conventional vertebroplasty

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
France	Hopital Nord	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Height of the targeted vertebrae		3 months after the procedure
Secondary	Height of the patient		3 months after the procedure
Secondary	Kyphotic angle		3 months after the procedure
Secondary	Analgesic properties of the strategies the day after the procedure	Pain will be assessed using a Visual Analogic Scale	The day after the procedure
Secondary	Analgesic properties of the strategies at 21 days	Pain will be assessed using a Visual Analogic Scale	21 days after the procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Size of cement leakage	Size will be described as significant or not significant as per investigator judgement	3 months after the procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale		3 months after the procedure