Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 280
- 主要终点
- Percentage of Participants reach objective response
研究概览
简要总结
This study will give comparison of the bone pain remission and the adverse reaction of Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in treatment of non-small cell lung cancer bone metastasis'pain relief or not.
详细描述
Further study details as provided by oncology center of Daping hospital
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
- •Pathology or cytology was diagnosed with non-small cell lung cancer, and bone metastases was confirmed by CT or MRI , and the patients have to need intervention treatment.
- •VAS score>2 points.
- •No paraplegia,
- •No pathological fractures of bone related events which require surgical intervention,
- •No major organ dysfunction,laboratory indexes meet the following requirements: Haemamoeba >4.0 x 10^9/L, Neutrophile granulocyte > 2 x 10^9/L, the platelet count>100 x 10^9/L, hemoglobin>100 g/L; Liver result: the serum bilirubin is lower than normal ceiling; ALT and AST is lower than the maximum normal 1.5 times; Cr<265 umol/l or 3.0 mg/dl, creatinine clearance>60 ml/min.
排除标准
- •The patients who have allergy of Bisphosphonates and zoledronate.
- •The patients who receive Molecular targeted therapy and chemotherapy within one month，The patients who receive Calcitonin and Aminoglycoside therapy in one week.
- •The patients who receive Pamidronic Acid in 28 days，The patients original sites receive radiotherapy before.
- •The patients who have history of thyroid surgery，receive tooth extraction in 2 weeks，and have been suffered from Bone Fracture and paraplegia.
- •The patients who have Serious internal medicine diseases and acute infection.
- •The patients With a history of psychiatric
- •Pregnancy or breast-feeding women, men have fertility requirements
- •Patients within clinical trials or not more than 30 days
研究组 & 干预措施
High dose group
Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle , a total of six cycle，Radiotherapy dose: 30Gy/10f
干预措施: Zoledronic acid (Drug)
High dose group
Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle , a total of six cycle，Radiotherapy dose: 30Gy/10f
干预措施: Radiotherapy (Radiation)
Low dose group
Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle, a total of six cycle，Radiotherapy dose: 15Gy/5f
干预措施: Zoledronic acid (Drug)
Low dose group
Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle, a total of six cycle，Radiotherapy dose: 15Gy/5f
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Percentage of Participants reach objective response
时间窗: Up to 1 month
Objective response is defined as the patients bone pain relief reach PR(Partial remission) or CR(Complete remission).and Objective response rate is defined as Objective response patients'percentage in total patients. Time evaluation points 1 month is the time after radiotherapy.
次要结局
- Kaplan-Meier Estimates for Overall Survival after bone metastases(every months up to the 12th month after treatment)
- Pain relief time in/after treatment(everyday in treatment and every months up to 12 monthes)
- Percentage of the osteogenic and the osteolytic sites reach objective response(every months up to the 12th month)
- Incidence of SRE(Skeletal-related events) again in Participants(every monthes up to the 12th month after treatment)
- Security of the therapy(everyday in treatment and every months up to the 12th month after treatment)
- Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.(every months up to the 12th month after treatment)
研究者
Wang Ge
Botanic physician
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University