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

Vertebral Metastasis Clinical Trial

— ZOSTER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951493
• Other study ID #: ICO-N-2018-14
• Status: Recruiting
• Phase: Phase 3
• Start date: June 23, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: April 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: Stéphane SUPIOT, MD
• Phone: +33240679900
• Email: stephane.supiot[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Vertebral Metastasis

Intervention

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.

Locations

Country	Name	City	State
France	Institut BERGONIE	Bordeaux
France	Institut de Cancérologie de Lorraine	Nancy
France	Hôpital Privé du Confluent	Nantes
France	Centre de Haute Energie	Nice
France	Hopital Lyon Sud	Pierre-Bénite
France	Centre Henri Becquerel	Rouen
France	Stéphane SUPIOT	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health	The determination of the DCRR includes Identification of care consumption ; The measurement of costs ; overall survival at 2 years ; Calculation of utilities using the EQ5D-5L questionnaire	24 months
Secondary	Survival without vertebral compression fractures		At 12 months and 24 months
Secondary	Pain control	Pain control will be assessed using a visual analogue scale (VAS) that measures pain intensity, prevents it, initiates or monitors drug or non-drug treatment, and the Brief Pain inventory, a questionnaire that quickly assesses the severity of pain and its impact on the patient's daily life.	at inclusion, 12 and 24 months
Secondary	Survival without bone complication		At 12 months and 24 months