CTRI/2016/02/006609进行中（未招募）未知
An observational study evaluating patterns of tumor response and impact on surgical margins following neoadjuvant chemotherapy (NACT) in locally advanced oral cavity tumors.
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- A
- 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
- Observational
入排标准
入选标准
- •1.Previously untreated borderline resectable oral cavity SCC i.e T4a lesions with skin induration.
- •2.Histological proven diagnosis of squamous cell cancer
- •3.Signed informed consent
- •4.Adequate organ function
- •Hematological- Hb > 9 g/dL, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
- •Liver functions- bilirubin <= 2 x upper limit normal (ULN), S. albumin >= 30 g/L.
- •Renal function- Creatinine <= 2 ULN, Creatinine clearance > 30 mL/min.
- •Performance score (KPS) > 80 or ECOG <= 2
排除标准
- •1. Distant metastasis present
- •2.Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections.
- •3.Locally advanced unresectable disease (T4b) or inoperable nodal disease
- •4.Patients not suitable for any chemotherapy.
- •5.Patient is currently enrolled in a clinical trial for another investigational therapy.
- •6.Pregnancy
研究者
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