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

Phase 1

• Conditions: Patients, men or women over 18 old, with inoperable vertebral bone metastases who must beneficit treatment with stereotactic radiotherapy.; MedDRA version: 20.0Level: LLTClassification code 10027484Term: Metastatic painSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10027474Term: MetastaticSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10049038Term: Metastatic bone painSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001209-26-FR
• Lead Sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ;Secondary Objective: ;Primary end point(s):