Clinical trial NCT02174107: Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.
Official title: Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spine Metastases
Keywords: Health economics
Percutaneous vertebroplasty
Radiation therapy
Painful spine metastases
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Bone is the most common site for metastasis. In breast and prostate cancers, 70% of patients dying of their cancer have evidence of metastatic bone disease \[Coleman, 2006\]. Depending on their localization, bone metastases can have debilitating consequences resulting in considerable morbidity and complex demands on health care resources. Bone spine metastases are the most frequent site observed in patients with cancer of the lung, prostate, breast and hemopoetic organs. The occurrence of spinal metastases in patients with advanced cancer can cause significant morbidity, with pain and/or neurological deficit adversely affecting the patients' quality of life.

Interventional radiology takes a large place in the treatment of bone metastases. Currently, vertebroplasty appears as the most satisfactory technique for stabilization of spine metastases offering a significant improvement of the quality of life. The analgesic effect is achieved very rapidly, i.e. usually within 24 hours post-procedure. Based on several publications, around 90% of patients reported rapid pain relief following vertebroplasty with 60 to 70% of complete pain relief \[Mendel, 2009\].

Radiotherapy also plays a very important role in the palliative treatment of the metastatic bone. Radiotherapy is effective and well tolerated. A reduction of the pain is noticed for 70 to 80 % of the patients and begins one or two weeks after the treatment. In all, the radiotherapy increases the quality of life of the patients and can reduce the intake of analgesics \[Lutz, 2011\].

In a lot of cases, vertebroplasty or radiotherapy can both be performed for a same painful patient (the National Institute for Health and Clinical Excellence (NICE) approved the use of vertebroplasty for patients with spinal metastases in November 2008). Radiotherapy remains the gold-standard treatment. However, vertebroplasty could be less costly and more effective compare to radiotherapy. In fact, the superiority of vertebroplasty has been demonstrated at least in the acute post-therapeutic period with (i) more rapid autonomy recovery, (ii) reduction of antalgic intakes, and potentially less side-effects.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Health economics evaluation
timeFrame: 6 months after the end ot treatment
Secondary outcomes:
measure: Budget impact analysis of vertebroplasty
timeFrame: 6 months after the end of treatment
Other outcomes:
measure: Assessment of pain reduction
timeFrame: 3 weeks, 3 months and 6 months after the end of treatment
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: HCL- Hopital Edouard Herriot
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Center Leon Berard
name: Bertrand BR RICHIOUD, MD
role: PRINCIPAL_INVESTIGATOR
References: