NCT00889590终止2 期
Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
Leiden University Medical Center4 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
研究概览
简要总结
This is a multicenter, randomised phase II trial in patients with high risk GCT.
Primary objective:
- Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care
Secondary objectives:
- Determine the relapse free survival
- Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
详细描述
GCT is a potentially malignant tumour that presents with a locally destructive osteolytic lesion. The high risk GCT are characterized by a high recurrence rate around the 40-45%. Zoledronic acid is a potent inhibitor of osteolysis and is capable of inducing osteoclast and stromal cell apoptosis, which makes it an attractive adjuvant treatment in 'high risk' GCT in order to improve clinical outcomes and reduce the recurrence rate.
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
- •Signed written informed consent
- •Male or female > 18 years of age
- •Histologically proven GCT treated with surgery
- •High risk GCT defined as minimal one or more of the following:
- •Recurrent GCT
- •GCT located in the pelvis, sacrum, spine, distal ulna or growth in soft tissue
- •GCT grade III
- •Pathological fracture in GCT
- •Absence of local adjuvant therapy (cryosurgery or phenol instillation)
- •Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l
- •Bilirubin level < 1.5 x ULN
- •ASAT and ALAT < 2.5 x ULN
- •Adequate renal function as defined by: serum creatinine clearance > 60 cc/min
- •Expected adequacy of follow-up
排除标准
- •Unresectable or metastatic GCT and grade IV GCT
- •Prior bisphosphonate usage, except preoperative treatment with zoledronic acid up to 3 months before surgery
- •Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Known hypersensitivity reaction to any of the components of the treatment
- •Pregnancy or lactating
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
研究组 & 干预措施
Zoledronic acid
Experimental
Adjuvant zoledronic acid
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
时间窗: 4 years
次要结局
- Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT(4 years)
- Determine the relapse free survival(4 years)
研究者
J.R. Kroep
MD PhD
Leiden University Medical Center
研究点 (4)
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