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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)

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ClinicalTrials.gov Identifier: NCT03951493
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
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.


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

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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
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


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.




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951493


Contacts
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Contact: Stéphane SUPIOT, MD +33240679900 stephane.supiot@ico.unicancer.fr

Locations
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France
Institut BERGONIE Recruiting
Bordeaux, France, 33000
Contact: Stéphanie BATARD, MD       s.batard@bordeaux.unicancer.fr   
Principal Investigator: Stéphanie BATARD, MD         
Institut de Cancérologie de Lorraine Recruiting
Nancy, France
Contact: JEAN-CHRISTOPHE FAIVRE, MD       jc.faivre@nancy.unicancer.fr   
Principal Investigator: Jean-Christophe FAIVRE, MD         
Hôpital Privé du Confluent Not yet recruiting
Nantes, France, 44277
Contact: Xavier BUTHAUD, MD       xavier.buthaud@groupeconfluent.fr   
Principal Investigator: Xavier BUTHAUD, MD         
Centre de Haute Energie Not yet recruiting
Nice, France, 06000
Contact: René-Jean BENSADOUN, MD       renejean.bensadoun@che-nice.com   
Principal Investigator: René-Jean BENSADOUN, MD         
Hopital Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Ariane LAPIERRE, MD       ariane.lapierre@chu-lyon.fr   
Principal Investigator: Ariane LAPIERRE, MD         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: SEBASTIEN THUREAU, MD       sebastien.thureau@chb.unicancer.fr   
Principal Investigator: Sébastien THUREAU, MD         
Stéphane SUPIOT Recruiting
Saint-Herblain, France, 44805
Contact: Stéphane SUPIOT, MD    +33240679900    stephane.supiot@ico.unicancer.fr   
Principal Investigator: Stéphane SUPIOT, MD         
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Study Director: Stéphane SUPIOT, MD ICO site SAINT HERBLAIN
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03951493    
Other Study ID Numbers: ICO-N-2018-14
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Hypo-fractured radiotherapy in stereotactic conditions (RSHF)
zoledronic acid
medico-economic
vertebral compressive fracture
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs