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

NCT02174107 | Terminated

• 1 other identifier: RADIOINTER01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Health economics; Percutaneous vertebroplasty; Radiation therapy; Painful spine metastases

Outcome Measures

Primary Outcomes (1)

• Health economics evaluation

  To perform a cost-utility analysis in order to provide recommendations to French decision-makers on the treatment of patients with painful spine metastases. Incremental cost-effectiveness ratio expressed in cost per quality adjusted life year (QALY) gained

  6 months after the end ot treatment

Secondary Outcomes (1)

• Budget impact analysis of vertebroplasty

  6 months after the end of treatment

Other Outcomes (1)

• Assessment of pain reduction

  3 weeks, 3 months and 6 months after the end of treatment

Study Arms (2)

Arm A

EXPERIMENTAL

Percutaneous vertebroplasty

Procedure: Percutaneous vertebroplasty

Arm B

EXPERIMENTAL

External radiotherapy

Radiation: External radiotherapy

Interventions

External radiotherapy RADIATION

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

Arm B

Percutaneous vertebroplasty PROCEDURE

Also known as: Vertebroplasty

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the day of consenting to the study
• Patient with at least a painful spine metastasis confirmed by MRI / CT scan,
• Localized pain at the lesion ≥ 4 (VAS),
• Bone axial metastasis localised on ≤ 6 different vertebrae,
• Histologically established diagnosis of cancer (lung, kidney, breast, prostate, melanoma, soft tissue sarcomas) other than hematologic malignancy, myeloma, brain tumor, germ cell tumor and bone sarcomas
• ECOG performance status 0 to 2 (Appendix 2)
• Minimum life expectancy of 6 months (Tokuhashi score \> 8 )
• Ability to understand and willingness for follow-up visits.
• Covered by a medical insurance
• Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment

You may not qualify if:

• Solitary metastasis
• SBRT indication
• Contra-indication to vertebroplasty
• Previous radiotherapy for pain management in the same area.
• Patient unable to lie prone
• Neurological deficit due to spinal cord compression,
• Active infection,
• Bleeding risk (platelets \< 50000 and PTT \> 1.5\*ULN),
• Risk of vertebral collapse (SINS score ≥ 13),
• Impossible follow-up for social, geographical, familial or psychological reasons,
• Patient deprived of freedom,
• Patient enrolled in another experimental surgical trial, with therapeutic endpoint,
• Pregnant or breastfeeding women,Pregnant or breastfeeding women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (7)

Institut Bergonié

Bordeaux, France

Location

Centre Leon Berard

Lyon, France

Location

HCL- Hopital Edouard Herriot

Lyon, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Institut Curie

Paris, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Institut Gustave Roussy

Villejuif, France

Location

MeSH Terms

Interventions

Vertebroplasty

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Bertrand BR RICHIOUD, MD

  Center Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

FR (7)