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

NCT03951493 | Unknown Phase 3

• 1 other identifier: ICO-N-2018-14
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 7

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.

Conditions

Vertebral Metastasis

Keywords

Hypo-fractured radiotherapy in stereotactic conditions (RSHF); zoledronic acid; medico-economic; vertebral compressive fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Survival without vertebral compression fractures

  At 12 months and 24 months

• Pain control

  at inclusion, 12 and 24 months

• Survival without bone complication

  At 12 months and 24 months

Study Arms (2)

RSHF + zoledronic acid

EXPERIMENTAL

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).

Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions

RSHF

ACTIVE COMPARATOR

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.

Radiation: Hypo-fractured radiotherapy in stereotactic conditions

Interventions

Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions COMBINATION_PRODUCT

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.

RSHF + zoledronic acid

Hypo-fractured radiotherapy in stereotactic conditions RADIATION

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.

RSHF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (7)

Institut BERGONIE

Bordeaux, 33000, France

RECRUITING

Institut de Cancérologie de Lorraine

Nancy, France

RECRUITING

Hôpital Privé du Confluent

Nantes, 44277, France

NOT YET RECRUITING

Centre de Haute Energie

Nice, 06000, France

NOT YET RECRUITING

Hopital Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Centre Henri Becquerel

Rouen, 76038, France

RECRUITING

Stéphane SUPIOT

Saint-Herblain, 44805, France

RECRUITING

MeSH Terms

Interventions

Zoledronic Acid; Solutions; Injections

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Stéphane SUPIOT, MD

  ICO site SAINT HERBLAIN

  STUDY DIRECTOR

Central Study Contacts

Stéphane SUPIOT, MD

CONTACT

+33240679900; stephane.supiot@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: June 23, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

FR (7)