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Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

NCT02174107 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-01-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.

Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,

This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :

* Arm A: Percutaneous vertebroplasty
* Arm B: External radiotherapy

This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).

Conditions

  • Spine Metastases

Interventions

RADIATION

External radiotherapy

The radiation technique used for each patient will be based on local clinical practices and on number of vertebae to treat between 1\*8 Gy; 5\*4 Gy and 10\*3 Gy

PROCEDURE

Percutaneous vertebroplasty

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Bertrand BR RICHIOUD, MD · Center Leon Berard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174107 on ClinicalTrials.gov