Multicentre, randomized, controlled, open-label, multi-centre medicoeconomic study evaluating the efficacy of adding zoledronic acid or denosumab to Stereotaxic radiotherapy in the treatment of vertebral metastases (ZOSTER)
- Conditions
- Patients, men or women over 18 old, with inoperable vertebral bone metastases who must beneficit treatment with stereotactic radiotherapyMedDRA version: 21.1Level: LLTClassification code: 10049038Term: Metastatic bone pain Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10027484Term: Metastatic pain Class: 10029104MedDRA version: 20.0Level: LLTClassification code: 10027474Term: Metastatic Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-513248-27-00
- Lead Sponsor
- Institut De Cancerologie De L Ouest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 202
Cancer with inoperable thoracic and/or lumbar vertebral metastases, Age = 18 years, Life expectancy greater than 1 year, WHO or PS = 2, Effective contraception for women of childbearing age, Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator, Patient affiliated to or benefiting from the social security system
Painful patient unable to maintain a supine position for 30 minutes despite analgesic treatment;, Patient under guardianship or unable to give consent;, Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons., Previous treatment with desonumab within the last 6 months or ongoing at inclusion., Patients with severe untreated hypocalcaemia., suppressed, Signs of neurological compression, Spinal cord compression or epidural involvement requiring surgery prior to radiotherapy;, Clinically significant hypersensitivity to zoledronic acid or denosumab, other bisphosphonates or any excipient;, A history of osteonecrosis of the jawbone or exposed bone or delayed healing after dental surgery;, Previous bisphosphonate treatment within the last 24 months or ongoing at inclusion;, Creatinine clearance < 30 ml/min;, Pregnant or breast-feeding woman;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method