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Multicentre, randomized, controlled, open-label, multi-centre medico-economic study evaluating the efficacy of adding zoledronic acid to Stereotaxic radiotherapy in the treatment of vertebral metastases

Multicentre, randomized, controlled, open-label, multi-centre medico-economic study evaluating the efficacy of adding zoledronic acid to Stereotaxic radiotherapy in the treatment of vertebral metastases

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2019-001209-26-FR
Enrollment
225
Registered
2019-05-13
Start date
2019-06-11
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients, men or women over 18 old, with inoperable vertebral bone metastases who must beneficit treatment with stereotactic radiotherapy. MedDRA version: 20.0 Level: LLT Classification code 10027484 Term: Metastatic pain System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10027474 Term: Metastatic System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10049038 Term: Metastatic bone pain System Organ Class: 100000004864

Interventions

Trade Name: acide zolédronique Pharmaceutical Form: Injection INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072-93-8

Sponsors

INSTITUT DE CANCEROLOGIE DE L'OUEST
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

France

Contacts

Public ContactPACTEAU Valérie

INSTITUT DE CANCEROLOGIE DE L'OUEST

drci@ico.unicancer.fr+33240679908

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026