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

Phase 3

• Conditions: Vertebral Metastasis
• Interventions: Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions; Radiation: Hypo-fractured radiotherapy in stereotactic conditions

• Registration Number: NCT03951493
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Study Start: 2020-06-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSHF + zoledronic acid	Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions	Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance).
RSHF	Hypo-fractured radiotherapy in stereotactic conditions	Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction.

Primary Outcome Measures

Name	Time	Method
Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health	24 months	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

Secondary Outcome Measures

Name	Time	Method
Pain control	at inclusion, 12 and 24 months	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.
Survival without bone complication	At 12 months and 24 months
Survival without vertebral compression fractures	At 12 months and 24 months

Trial Locations

Locations (7)

Hôpital Privé du Confluent; 🇫🇷 Nantes, France

Hopital Lyon Sud; 🇫🇷 Pierre-Bénite, France

Centre de Haute Energie; 🇫🇷 Nice, France

Institut BERGONIE; 🇫🇷 Bordeaux, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Stéphane SUPIOT; 🇫🇷 Saint-Herblain, France

Institut de Cancérologie de Lorraine; 🇫🇷 Nancy, France