Metastatic Renal Cell CarcinomaPhase 3MOSCARNCT03408652
Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies
A Phase 3 study testing denosumab in people with Metastatic Renal Cell Carcinoma, run by Centre Leon Berard at 1 site in France.
Trial summary
Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone metastases under targeted therapy for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2019to 22 Jun 2020
- 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
- Age ≥ 18 years.
- Histologically proven mRCC.
- Administration of one of the systemic agents in use for the treatment of mRCC (no more than three prior systemic therapy regimens). Patients with at least 6 months of 1st line treatment and a bone event may be included.
- More than 1 bone metastasis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
- Adequate renal function (serum creatinine ≤ 200 mmol/L or creatinine clearance ≥ 30 mL/min according to Cockroft formula or MDRD formula for patients older than 65 years).
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- Covered by a medical insurance.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Signed informed consent.
- Accepting to use effective contraception during study treatment and within 5 months after final dose of study therapy.
Who cannot join
- Prior bisphosphonate or denosumab treatment in the year before inclusion.
- Imminent or ongoing nerve or spinal compression as per the investigator's judgement.
- Ongoing first-line therapy, started for less than 6 months (patients with BM at time of metastases diagnosis will initially benefit from the angiogenesis targeted agents used and are not at higher risk).
- Anticancer treatment under investigation.
- Paraneoplastic hypercalcemia (corrected total calcium > 2.7 mmol/L).
- Grade 4 toxicity under previous targeted agents.
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- Liver failure (AST and/or ALT ≥ 5.0 x upper limit of normal (ULN) or total bilirubin beyond normal limits).
- Severe hypocalcaemia > 2.8 mmol/l.
- Fructose intolerance.
- Invasive dental procedure (i.e. tooth extraction, dental implants, oral surgery) within the 10 days prior to randomization or required dental procedures at the pre-inclusion dental examination.
- Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements.
- Pregnant or breastfeeding woman. Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior inclusion.
- Life expectancy ≤ 3 months.
- Participation to another clinical trial that might interfere with the evaluation of the main criterion.
- Known hypersensitivity to the active substance or to any of the excipients of bisphosphonate or denosumab.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Phase III Study Evaluating the Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies
Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone metastases under targeted therapy for Metastatic Renal Cell Carcinoma.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- denosumab
- Keywords
- Bone Metastases
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denosumabDrug
Also called zoledronic acid
Single subcutaneous injection of denosumab 120 mg every 4 weeks One intravenous infusion of zoledronic acid 4 mg every 4 weeks, according to labelled use.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | bone targeted treatment (denosumab or zoledronic acid) Receives: Drug: denosumab |
| Arm B | No intervention | no specific treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first Skeletal Related Event
Defined as the time from randomization to first SRE. Patients without event will be censored at the time of the last clinical evaluation.
Measured: Up to 54 months after the first inclusion
Secondary outcomes (11)
Number of specific event-free survivals
Specific times from randomization to appearance of the first Skeletal Related Event.
Measured: Up to 54 months after the first inclusion
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Incidence of adverse events (AEs) assessed using the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4 grading scale, specific registration of ONJ or other osteonecrosis and rate of skeletal event per patient during study duration
Measured: Every 3 months until the 18th month for each patient
Evolution of pain severity
Proportion of patients with a clinically meaningful change in pain severity evaluated using a numerical rating scale (NRS)
Measured: Every 3 months until the 18th month for each patient
Evolution of pain
Proportion of patients that shifted from not taking a strong opioid at baseline
Measured: Every 3 months until the 18th month for each patient
Patient's condition evaluation
"Functional Assessment of cancer Therapy-General (FACT-G)" questionnaire, made of 27 items measuring the respondents' health state, each of which is answered using a five-point scale from 0 (not at all) to 4 (very much). Questions are phrased so that higher numbers indicate a better health state. Subscale scores are added to obtain total score.
Measured: Up to 9 months for each patient (evaluated at baseline, months 3, 6, 9)
Patient's condition evaluation
"EuroQoL 5 Dimensions 5 Levels" questionnaire is a scale used in the health state description. Each items is a three-level scale : having no problems, having some or moderate problems, being unable to do/having extreme problems.The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Measured: Up to 18 months for each patient (evaluated at baseline, months 3, 6, 9 and 18)
Overall survival
Measured from the date of randomization to the date of death from any cause
Measured: Up to 54 months after the first inclusion
Evaluation of the different practices for bone metastases treatments
Financial evaluation of centers' practices (home or hospitalization)
Measured: Up to 18 months for each patient
Cost-utility analysis
All the hospitalization costs will be collected during the timeframe: outpatient, inpatient, and home care
Measured: Up to 18 months for each patient
Cost-effectiveness analyses
All the hospitalization costs will be collected during the timeframe: outpatient, inpatient, and home care
Measured: Up to 18 months for each patient
Budget impact analysis
Quantification of financial consequences of rolling out this kind of medical supportive care strategy throughout the health system.
Measured: Up to 18 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start15 Mar 2019
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie NEGRIER, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408652
- Sponsor's protocol ID
- MOSCAR
- Other IDs
- 2017-004075-31, 2017
- Acronym
- MOSCAR
- Status last verified
- Oct 2021
- First submitted
- 8 Jan 2018
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase III Study Evaluating the Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies
- ClinicalTrials.gov ID
- NCT03408652
- Acronym / sponsor ID
- MOSCAR / MOSCAR
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Bone Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 24 Jan 2018 (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.
Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone metastases under targeted therapy for Metastatic Renal Cell Carcinoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: denosumabbone targeted treatment (denosumab or zoledronic acid) |
| Arm B | No intervention | –no specific treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Histologically proven mRCC.
- Administration of one of the systemic agents in use for the treatment of mRCC (no more than three prior systemic therapy regimens). Patients with at least 6 months of 1st line treatment and a bone event may be included.
- More than 1 bone metastasis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
Key exclusion criteria (15 listed)
- Prior bisphosphonate or denosumab treatment in the year before inclusion.
- Imminent or ongoing nerve or spinal compression as per the investigator's judgement.
- Ongoing first-line therapy, started for less than 6 months (patients with BM at time of metastases diagnosis will initially benefit from the angiogenesis targeted agents used and are not at higher risk).
- Anticancer treatment under investigation.
- Paraneoplastic hypercalcemia (corrected total calcium > 2.7 mmol/L).
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 |
|---|---|---|
| denosumabAlso: zoledronic acidSingle subcutaneous injection of denosumab 120 mg every 4 weeks One intravenous infusion of zoledronic acid 4 mg every 4 weeks, according to labelled use. | Drug | Arm A |
Primary outcome
Time to first Skeletal Related Event
Time frame: Up to 54 months after the first inclusion
Defined as the time from randomization to first SRE. Patients without event will be censored at the time of the last clinical evaluation.
11 secondary outcomes
Number of specific event-free survivals
Time frame: Up to 54 months after the first inclusion
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Every 3 months until the 18th month for each patient
Evolution of pain severity
Time frame: Every 3 months until the 18th month for each patient
Evolution of pain
Time frame: Every 3 months until the 18th month for each patient
Patient's condition evaluation
Time frame: Up to 9 months for each patient (evaluated at baseline, months 3, 6, 9)
Patient's condition evaluation
Time frame: Up to 18 months for each patient (evaluated at baseline, months 3, 6, 9 and 18)
Overall survival
Time frame: Up to 54 months after the first inclusion
Evaluation of the different practices for bone metastases treatments
Time frame: Up to 18 months for each patient
Cost-utility analysis
Time frame: Up to 18 months for each patient
Cost-effectiveness analyses
Time frame: Up to 18 months for each patient
Budget impact analysis
Time frame: Up to 18 months for each patient
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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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.
Sylvie NEGRIER, PhD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denosumab in people with Metastatic Renal Cell Carcinoma, run by Centre Leon Berard at 1 site 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first Skeletal Related Event (time frame: Up to 54 months after the first inclusion). 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 22 Oct 2021.