A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
研究概览
简要总结
The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
详细描述
Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.
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
- •Written informed consent
- •Age ≥ 18 years
- •Histological or cytological evidence of lung cancer
- •Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan
- •Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS
- •Patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed)
- •ECOG Performance status of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease)
- •Adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/L); ALT or AST within 2 times the upper limit of the normal range
排除标准
- •Patients with an uncontrolled infection
- •Hypocalcemia
- •Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate
- •Patients with known hypersensitivity to any of the components of ibandronic acid
- •Patients who are pregnant or lactating
- •Radiotherapy to bone within the 28 days prior inclusion or during the trial duration
- •Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
研究组 & 干预措施
A
Intravenous infusion of either 6mg Bondronat on three consecutive days
干预措施: Ibandronate (Bondronat) (Drug)
B
Intravenous infusion of 6mg Bondronat on one day
干预措施: Ibandronate (Bondronat) (Drug)
结局指标
主要结局
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
时间窗: 1 month
次要结局
- Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters(1 month)
研究者
Yi-Long Wu
Professor
Chinese Society of Lung Cancer