Adjuvant zoledronic acid in ‘high risk’ Giant Cell Tumour of bone (GCT) - A randomized phase II study - - HR-GCT

eids Universitair Medisch Centrum0 个研究点目标入组 90 人开始时间: 2008年10月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-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 joint/soft tissue
•GCT grade III
•Pathological fracture in GCT
•absence of local adjuvant therapy
•-WHO performance status 0 - 2
•-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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-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

发起方