A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer (REaCT-Hold BMA)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- Health related quality of life scores
研究概览
简要总结
The investigators propose to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA
- •Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases
- •Age 18 years or older
- •Able to provide verbal consent
排除标准
- •Definite contraindication for BMA
- •History of, or current evidence of osteonecrosis of the jaw
- •Radiotherapy or surgery to the bone planned within 4 weeks after randomization
- •Current hypercalcemia defined as corrected serum calcium of > 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)
研究组 & 干预措施
De-escalate BMA to once every 24 weeks
Bone modifying agent once every 24 weeks.
干预措施: Bone modifying agent (Drug)
Standard BMA frequency
Continue standard BMA frequency (every 4 or 12 weeks) as administered previously. If a change in BMA frequency (every 4 weeks to every 12 weeks OR every 12 weeks to every 4 weeks) was prescribed by the physician, this would still be considered on protocol treatment.
干预措施: Bone modifying agent (Drug)
结局指标
主要结局
Health related quality of life scores
时间窗: 48 weeks after randomization (one year of treatment)
Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting.
次要结局
- Time to development of Symptomatic Skeletal Event(2 years post-randomization)
- Quality of life of cancer patients using the EORTC-QLQ-C30(48 weeks post-randomization)
- Symptomatic Skeletal Event-free survival(2 years post-randomization)
- Incremental cost-effectiveness rations(2 years post-randomization)
- Symptomatic Skeletal Event (SSE)(2 years post-randomization)
- Quality of life of cancer patients using the EORTC-QLQ-BM22(48 weeks post-randomization)
- Skeletal morbidity(2 years post-randomization)
- BMA-related toxicity rates(2 years post-randomization)