CTRI/2024/07/071188尚未招募2 期
A Phase 2 Open label Randomised Controlled Trial Comparing Modified TPF with Docetaxel-Platinum Regimen as Neoadjuvant Chemotherapy in Locally Advanced Resectable Oral Cavity Cancer - NeoORA
AIIMS, New Delhi0 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
- •Histologically confirmed squamous cell carcinoma of the oral cavity
- •Patients with a resectable lesion, with clinical stage III or IVA disease (T3N0 or T1-3N1-2M0 or T4aN0-2M0 according to Union for International Cancer Control [2018]).
- •ECOG PS 0-1
- •Meeting the following standard values of general laboratory tests completed within 7 days prior to randomization and values are within the parameters required by the protocol:
- •a) WBC count more than 4,000/µL, hemoglobin more than 8 g/L, platelet count more than 100,000/µL
- •b) ALT and AST less than 2.5× the upper limit of normal
- •c) Total bilirubin less than 1.5× the upper limit of normal
- •d) Serum creatinine less than 1.5× the upper limit of normal
- •Written informed consent.
排除标准
- •Distant metastasis or other cancers
- •Have undergone surgery involving primary tumor or lymph nodes (except diagnostic biopsy)
- •Have received any prior radiotherapy or chemotherapy
- •Have had other malignancies within 5 years
- •Have creatinine clearance less than 60 mL/min.
- •Cisplatin ineligible patients
- •Unstable angina within 3 weeks, or with a history of myocardial infarction within last 6 months
- •Pregnant or breastfeeding females or those not willing for contraception
研究者
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