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出境医 / 临床实验 / Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases (ZOSTER)

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

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.


Condition or disease Intervention/treatment Phase
Vertebral Metastasis Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions Radiation: Hypo-fractured radiotherapy in stereotactic conditions Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Survival without vertebral compression fractures [ Time Frame: At 12 months and 24 months ]
  2. 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.

  3. Survival without bone complication [ Time Frame: At 12 months and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: KAREN CLEMENT-COLMOU, MD 0240679325 Karen.Clement-Colmou@ico.unicancer.fr
Contact: SUPIOT STEPHANE, MD 0240679913 stephane.supiot@ico.unicancer.fr

Locations
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France
Centre Oscar Lambret
Lille, France, 59000
Institut de Cancérologie de Lorraine
Nancy, France
Contact: JEAN-CHRISTOPHE FAIVRE, MD       jc.faivre@nancy.unicancer.fr   
Hopital Lyon Sud
Pierre-Bénite, France, 69310
Contact: OLIVIER CHAPET, MD       olivier.chapet@chu-lyon.fr   
Centre Eugène Marquis
Rennes, France, 35000
Contact: RENAUD DE CREVOISIER, MD       r.de-crevoisier@rennes.unicancer.fr   
Centre Henri Becquerel
Rouen, France, 76038
Contact: SEBASTIEN THUREAU, MD       sebastien.thureau@chb.unicancer.fr   
Institut de Cancérologie de l'OUEST
Saint-Herblain, France, 44805
Contact: Karen CLEMENT-COLMOU, MD    +33240679325    Karen.Clement-Colmou@ico.unicancer.fr   
Institut de Cancérologie de la Loire
Vandœuvre-lès-Nancy, France, 54519
Contact: NICOLAS MAGNE, MD       nicolas.magne@icloire.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
Layout table for investigator information
Principal Investigator: KAREN CLEMENT-COLMOU, MD ICO site SAINT HERBLAIN
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 15, 2019
Estimated Study Start Date  ICMJE September 2, 2019
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Survival without vertebral compression fractures [ Time Frame: 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.
  • Survival without bone complication [ Time Frame: At 12 months and 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vertebral Metastasis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions
  • 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.
    Intervention: Radiation: Hypo-fractured radiotherapy in stereotactic conditions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: KAREN CLEMENT-COLMOU, MD 0240679325 Karen.Clement-Colmou@ico.unicancer.fr
Contact: SUPIOT STEPHANE, MD 0240679913 stephane.supiot@ico.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951493
Other Study ID Numbers  ICMJE ICO-N-2018-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Cancerologie de l'Ouest
Study Sponsor  ICMJE Institut Cancerologie de l'Ouest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: KAREN CLEMENT-COLMOU, MD ICO site SAINT HERBLAIN
PRS Account Institut Cancerologie de l'Ouest
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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