CTRI/2011/091/000189已完成2 期
Evaluation of Zolendronic acid as a single agent or an adjuvant to chemotherapy in the management of high grade osteosarcoma - ZOL TRIA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria for part 1-
- •1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
- •2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
- •3. Patients are willing and able to afford the standard chemotherapy.
- •Inclusion criteria for part 2-
- •1.Patients (between the ages of 18 to 65 years) with a high grade osteosarcoma of the extremity unable to afford or take the standard chemotherapy
- •2.Relapsed osteosarcoma unsuitable or unable to afford second line chemotherapy
排除标准
- •Exclusion criteria for part 1-
- •1.Non-extremity sarcomas. (pelvis and spine)
- •2.Age less than 18 years or greater than 65 years
- •3.Metastatic at presentation
- •4.Pregnant or lactating women
- •5.Renal dysfunction in the form of elevated serum creatinine
- •6.Dental treatment anticipated after evaluation.
- •7.Patients who have received or are likely to receive steroids.
- •Exclusion criteria for part 2-
- •1.Able to take some chemotherapy or second line chemotherapy
- •2.Renal dysfunction in the form of elevated serum creatinine
- •3.Dental treatment anticipated after evaluation.
- •4.Unable to follow-up regularly as required by the protocol.
研究者
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