CTRI/2024/02/062905尚未招募2 期
Functional Outcome of Denosumab in the management of Giant Cell Tumour of Bone. - NI
Dr Sanyam Rathi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
- •1.Diagnosed cases of Giant Cell Tumour Of Bone
- •2.Patients with no medical contraindication
- •3.Adults or skeletally mature adolescents (aged =12 years) weighing at least 45 kg , a Karnofsky performance status of 50% or higher (or Eastern Cooperative Oncology Group status 0, 1, or 2), and measurable active disease within 1 year of study enrolment.
- •4. Campanacci grades 2 and 3 will be included that is
- •II- Extensive intaosseous lesion with thin cortex, cortical continuity
- •III- Destructive radiolucent lesion with cortical break and soft tissue extension)
排除标准
- •1.Age of patients less than 12 years
- •2.Patients with active local infection at the site.
- •3.Patients with a known or suspected diagnosis of sarcoma, non-GCTB giant-cell-rich tumours, brown cell tumour of bone, or Paget disease; patients with a history or current evidence of osteonecrosis or osteomyelitis of the jaw; or those who required oral surgery or had unhealed dental or oral surgery are excluded
- •4.Pregnant Females
- •5.Patients hypersensitive to denosumab or any of the components of formulation
- •6.Preexisting hypocalcemia
- •7.Campanacci Grade I
- •I-Intraosseous lesion with Intact Cortex
研究者
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