Clinical trial NCT03951493: Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases
Official title: Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vertebral Metastasis
Keywords: Hypo-fractured radiotherapy in stereotactic conditions (RSHF)
zoledronic acid
medico-economic
vertebral compressive fracture
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 225
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: Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.


Eligibility criteria: Inclusion Criteria:

* Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
* Age ≥ 18 years old ;
* Life expectancy greater than 1 year;
* OMS or PS ≤ 2 ;
* Effective contraception for women of childbearing age;
* Patient information and free, informed and written consent, signed by the patient and investigator;
* Patient affiliated or beneficiary of the social security system.

Exclusion Criteria:

* Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
* Painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment;
* Patient who has received external irradiation from the proposed irradiation area \> 20 Gy ;
* Signs of neurological compression;
* Spinal cord compression or epidural damage requiring surgery before radiotherapy;
* Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient;
* History of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery;
* Previous (less than 2 years) or ongoing treatment with a bisphosphonate;
* Creatinine clearance \< 30 ml/min;
* Pregnant or breastfeeding woman;
* Patient protected or under guardianship or incapable of giving consent;
* Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

Primary outcomes:
measure: Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
timeFrame: 24 months
Secondary outcomes:
measure: Survival without vertebral compression fractures
timeFrame: At 12 months and 24 months
measure: Pain control
timeFrame: at inclusion, 12 and 24 months
measure: Survival without bone complication
timeFrame: At 12 months and 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut BERGONIE
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nice
country: France
facility: Centre de Haute Energie
city: Pierre-Bénite
country: France
facility: Hopital Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Herblain
country: France
facility: Stéphane SUPIOT
Study officials:
affiliation: ICO site SAINT HERBLAIN
name: Stéphane SUPIOT, MD
role: STUDY_DIRECTOR
References: