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

Centre Leon Berard1 site in 1 country1 target enrollmentMarch 15, 2019

ConditionsMetastatic Renal Cell Carcinoma

Interventionsdenosumab

Drugsdenosumab

Overview

Phase: Phase 3
Intervention: denosumab
Conditions: Metastatic Renal Cell Carcinoma
Sponsor: Centre Leon Berard
Enrollment: 1
Locations: 1
Primary Endpoint: Time to first Skeletal Related Event
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 Metastatic Renal Cell Carcinoma.

Registry

clinicaltrials.gov

Start Date

March 15, 2019

End Date

June 22, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Leon Berard

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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) ≤
•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).
•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

Arm A

bone targeted treatment (denosumab or zoledronic acid)

Intervention: denosumab

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Evolution of pain(Every 3 months until the 18th month for each patient)
Number of specific event-free survivals(Up to 54 months after the first inclusion)
Overall survival(Up to 54 months after the first inclusion)
Cost-effectiveness analyses(Up to 18 months for each patient)
Budget impact analysis(Up to 18 months for each patient)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Every 3 months until the 18th month for each patient)
Evolution of pain severity(Every 3 months until the 18th month for each patient)
Patient's condition evaluation(Up to 18 months for each patient (evaluated at baseline, months 3, 6, 9 and 18))
Cost-utility analysis(Up to 18 months for each patient)
Evaluation of the different practices for bone metastases treatments(Up to 18 months for each patient)