Status:
TERMINATED
Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies
Lead Sponsor:
Centre Leon Berard
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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) ve...
Eligibility Criteria
Inclusion
- 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).
- 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
- 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.
- 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.
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03408652
Start Date
March 15 2019
End Date
June 22 2020
Last Update
October 22 2021
Active Locations (1)
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1
Centre Leon Berard
Lyon, France, 69008