NCT03408652终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Time to first Skeletal Related Event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A
Experimental
bone targeted treatment (denosumab or zoledronic acid)
干预措施: denosumab (Drug)
结局指标
主要结局
Time to first Skeletal Related Event
时间窗: 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.
次要结局
- 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)
研究者
研究点 (1)
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