A Phase 3 interventional study of denosumab in Metastatic Renal Cell Carcinoma, sponsored by Centre Leon Berard. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by Centre Leon Berard · Phase 3, Interventional, and Supportive care
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.
Exclusion Criteria:
bone targeted treatment (denosumab or zoledronic acid)
Drug: denosumab
no specific treatment
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.
Also known as: zoledronic acid
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.
Time frame: Up to 54 months after the first inclusion
Number of specific event-free survivals
Specific times from randomization to appearance of the first Skeletal Related Event.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 18 months for each patient
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Centre Leon Berard