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临床试验/CTRI/2020/10/028269
CTRI/2020/10/028269招募中2 期

A phase II study to evaluate the efficacy of cisplatin and gemcitabine based neoadjuvant chemotherapy followed by dysphagia optimized intensity modulated radiotherapy with concomitant cisplatin and correlation of clinical outcome with serial plasma Epstein Barr Virus DNA titre in patients with locally advanced nasopharyngeal carcinoma.

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
招募中
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

  • Carcinoma nasopharynx stage II-IVA.,
  • Histological proof of nasopharyngeal squamous cell carcinoma (keratinizing squamous cell carcinoma, non-keratinizing squamous cell carcinoma including undifferentiated and poorly differentiated nasopharyngeal carcinoma) confirmed by p40 immunohistochemistry.,
  • Eastern Cooperative Oncology Group performance status 0-3.,
  • Absence of any uncontrolled medical comorbidity.
  • Adequate end-organ functions and bone marrow reserve.,
  • Negative viral serology markers(HIV, HBsAg, HCV).,
  • Informed Consent.

排除标准

  • ECOG performance status 4.,
  • Immunocompromised status like HIV sero-positivity, organ transplant recipients, congenital immunodeficiency syndromes.,
  • Any prior oncologic treatment with surgery, chemotherapy or radiotherapy.,
  • Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy e.g., renal disease, hepatic disease, cardiorespiratory disease, diabetes mellitus.,
  • Other histological types of nasopharyngeal carcinomas eg. neuroendocrine carcinomas., adenocarcinomas, and salivary gland type carcinomas.

研究者

发起方
AIIMS New Delhi

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