Vertebral MetastasisPhase 3ZOSTERNCT03951493
Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases
A Phase 3 study testing Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions and Hypo-fractured radiotherapy in stereotactic conditions in people with Vertebral Metastasis, run by Institut Cancerologie de l'Ouest at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Metastasis
- What is being tested?
- Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions and Hypo-fractured radiotherapy in stereotactic conditions
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 7 sitesFrance
- Study dates
- 23 Jun 2020to 1 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Institut BERGONIE
Bordeaux, 33000
Stéphanie BATARD, MD, s.batard@bordeaux.unicancer.fr
Stéphanie BATARD, MD
- Recruiting
Institut de Cancérologie de Lorraine
Nancy
JEAN-CHRISTOPHE FAIVRE, MD, jc.faivre@nancy.unicancer.fr
Jean-Christophe FAIVRE, MD
- Not yet recruiting
Hôpital Privé du Confluent
Nantes, 44277
Xavier BUTHAUD, MD, xavier.buthaud@groupeconfluent.fr
Xavier BUTHAUD, MD
- Not yet recruiting
Centre de Haute Energie
Nice, 06000
René-Jean BENSADOUN, MD, renejean.bensadoun@che-nice.com
René-Jean BENSADOUN, MD
- Recruiting
Hopital Lyon Sud
Pierre-Bénite, 69310
Ariane LAPIERRE, MD, ariane.lapierre@chu-lyon.fr
Ariane LAPIERRE, MD
- Recruiting
Centre Henri Becquerel
Rouen, 76038
SEBASTIEN THUREAU, MD, sebastien.thureau@chb.unicancer.fr
Sébastien THUREAU, MD
- Recruiting
Stéphane SUPIOT
Saint-Herblain, 44805
Stéphane SUPIOT, MD, +33240679900, stephane.supiot@ico.unicancer.fr
Stéphane SUPIOT, MD
About this study
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
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.
- Conditions
- Vertebral Metastasis
- Being tested
- Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions, Hypo-fractured radiotherapy in stereotactic conditions
- Keywords
- Hypo-fractured radiotherapy in stereotactic conditions (RSHF), zoledronic acid, medico-economic, vertebral compressive fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditionsCombination product
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 conditionsRadiation
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 group | Role | What they receive |
|---|---|---|
| RSHF + zoledronic acid | Experimental | 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). Receives: Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions |
| RSHF | Active comparator | 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. Receives: Radiation: Hypo-fractured radiotherapy in stereotactic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (3)
Survival without vertebral compression fractures
Measured: At 12 months and 24 months
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.
Measured: at inclusion, 12 and 24 months
Survival without bone complication
Measured: At 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start23 Jun 2020
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane SUPIOT, MD, Study director, ICO site SAINT HERBLAIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951493
- Sponsor's protocol ID
- ICO-N-2018-14
- Acronym
- ZOSTER
- Status last verified
- Apr 2022
- First submitted
- 10 May 2019
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03951493
- Acronym / sponsor ID
- ZOSTER / ICO-N-2018-14
- Conditions
- Vertebral Metastasis
- Keywords
- Hypo-fractured radiotherapy in stereotactic conditions (RSHF), zoledronic acid, medico-economic, vertebral compressive fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSHF + zoledronic acid | Experimental | Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditionsPatients 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). |
| RSHF | Active comparator | Radiation: Hypo-fractured radiotherapy in stereotactic conditionsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditionsAll 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. | Combination product | RSHF + zoledronic acid |
| Hypo-fractured radiotherapy in stereotactic conditionsAll 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. | Radiation | RSHF |
Primary outcome
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
3 secondary outcomes
Survival without vertebral compression fractures
Time frame: At 12 months and 24 months
Pain control
Time frame: at inclusion, 12 and 24 months
Survival without bone complication
Time frame: At 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane SUPIOT, MD study director
ICO site SAINT HERBLAIN
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions and Hypo-fractured radiotherapy in stereotactic conditions in people with Vertebral Metastasis, run by Institut Cancerologie de l'Ouest at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane SUPIOT, MD (+33240679900, stephane.supiot@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.