Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases
NCT ID: NCT03951493
Last Updated: 2022-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
225 participants
INTERVENTIONAL
2020-06-23
2023-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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Stéphane SUPIOT, MD
Role: STUDY_DIRECTOR
ICO site SAINT HERBLAIN
Locations
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Institut BERGONIE
Bordeaux, , France
Institut de Cancérologie de Lorraine
Nancy, , France
Hôpital Privé du Confluent
Nantes, , France
Centre de Haute Energie
Nice, , France
Hopital Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Stéphane SUPIOT
Saint-Herblain, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICO-N-2018-14
Identifier Type: -
Identifier Source: org_study_id
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