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

April 21, 2022 updated by: Institut Cancerologie de l'Ouest

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSHF + zoledronic acid
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

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.
Active Comparator: RSHF
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
Time Frame: 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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival without vertebral compression fractures
Time Frame: At 12 months and 24 months
At 12 months and 24 months
Pain control
Time Frame: 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.
at inclusion, 12 and 24 months
Survival without bone complication
Time Frame: At 12 months and 24 months
At 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Study Director: Stéphane SUPIOT, MD, ICO site SAINT HERBLAIN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-N-2018-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe