NCT03951493

Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vertebral Metastasis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions	All patients receive radiotherapy i.e. treatment on D1, D3 and D5. Several radiotherapy schemes are possible: * 20 Gy in 1 fraction; * 27 Gy in 3 fractions of 9 Gy * 30 Gy in 5 fractions of 6 Gy. All patients in the experimental arm receive an intravenous injection of at least 15 minutes of 4 mg zoledronic acid every month for 12 months. The first injection must be made no more than 3 weeks before the first day of radiotherapy. It can be performed up to J1 of radiotherapy. The injections will be carried out either at the patient's home by the nurses or in the investigator centre.
RADIATION	Hypo-fractured radiotherapy in stereotactic conditions	All patients receive radiotherapy i.e. treatment on D1, D3 and D5. Several radiotherapy schemes are possible: * 20 Gy in 1 fraction; * 27 Gy in 3 fractions of 9 Gy * 30 Gy in 5 fractions of 6 Gy.

Timeline

• Start date: 2020-06-23
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-05-15
• Last updated: 2022-04-28

Locations

7 sites across 1 country: France