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

Primary Purpose

Vertebral Metastasis

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

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

Hypo-fractured radiotherapy in stereotactic conditions

About this trial

This is an interventional treatment trial for Vertebral Metastasis focused on measuring Hypo-fractured radiotherapy in stereotactic conditions (RSHF), zoledronic acid, medico-economic, vertebral compressive fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institut BERGONIERecruiting
Institut de Cancérologie de LorraineRecruiting
Hôpital Privé du Confluent
Centre de Haute Energie
Hopital Lyon SudRecruiting
Centre Henri BecquerelRecruiting
Stéphane SUPIOTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RSHF + zoledronic acid

RSHF

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival without vertebral compression fractures

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.

Survival without bone complication

Full Information

NCT ID

NCT03951493

First Posted

May 10, 2019

Last Updated

April 21, 2022

Sponsor

Institut Cancerologie de l'Ouest

1. Study Identification

Unique Protocol Identification Number

NCT03951493

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 23, 2020 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vertebral Metastasis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RSHF + zoledronic acid

Arm Type

Experimental

Arm Description

Arm Title

RSHF

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Combination Product

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Hypo-fractured radiotherapy in stereotactic conditions

Intervention Description

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.

Primary Outcome Measure Information:

Title

Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Survival without vertebral compression fractures

Time Frame

At 12 months and 24 months

Title

Pain control

Description

Time Frame

at inclusion, 12 and 24 months

Title

Survival without bone complication

Time Frame

At 12 months and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphane SUPIOT, MD

Phone

+33240679900

stephane.supiot@ico.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stéphane SUPIOT, MD

Organizational Affiliation

ICO site SAINT HERBLAIN

Official's Role

Study Director

Facility Information:

Facility Name

Institut BERGONIE

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphanie BATARD, MD

s.batard@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Stéphanie BATARD, MD

Facility Name

Institut de Cancérologie de Lorraine

City

Nancy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JEAN-CHRISTOPHE FAIVRE, MD

jc.faivre@nancy.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Jean-Christophe FAIVRE, MD

Facility Name

Hôpital Privé du Confluent

City

Nantes

ZIP/Postal Code

44277

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xavier BUTHAUD, MD

xavier.buthaud@groupeconfluent.fr

First Name & Middle Initial & Last Name & Degree

Xavier BUTHAUD, MD

Facility Name

Centre de Haute Energie

City

Nice

ZIP/Postal Code

06000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

René-Jean BENSADOUN, MD

renejean.bensadoun@che-nice.com

First Name & Middle Initial & Last Name & Degree

René-Jean BENSADOUN, MD

Facility Name

Hopital Lyon Sud

City

Pierre-Bénite

ZIP/Postal Code

69310

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ariane LAPIERRE, MD

ariane.lapierre@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Ariane LAPIERRE, MD

Facility Name

Centre Henri Becquerel

City

Rouen

ZIP/Postal Code

76038

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

SEBASTIEN THUREAU, MD

sebastien.thureau@chb.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Sébastien THUREAU, MD

Facility Name

Stéphane SUPIOT

City

Saint-Herblain

ZIP/Postal Code

44805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphane SUPIOT, MD

Phone

+33240679900

stephane.supiot@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Stéphane SUPIOT, MD

12. IPD Sharing Statement

Learn more about this trial

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

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