ZOSTER
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
Sponsor study identifier
interventional
225
1 country
7
Study Start
June 23, 2020
Actual (reported)Primary Completion
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2019
Actual (reported)May 15, 2019
Actual (reported)June 23, 2020
Actual (reported)November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment and procedure
Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordInstitut BERGONIE
Bordeaux, 33000, France
Institut de Cancérologie de Lorraine
Nancy, France
Stéphane SUPIOT, MD
ICO site SAINT HERBLAIN
First Submitted
May 10, 2019
First Posted
May 15, 2019
Study Start
June 23, 2020
Actual (reported)Primary Completion
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Hôpital Privé du Confluent
Nantes, 44277, France
Centre de Haute Energie
Nice, 06000, France
Hopital Lyon Sud
Pierre-Bénite, 69310, France
Centre Henri Becquerel
Rouen, 76038, France
Stéphane SUPIOT
Saint-Herblain, 44805, France
Study Completion
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 28, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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