A prospective study of therapeutic outcome in locally advanced Head and Neck Cancers treated with chemo-radiation and the hypoxic radio- sensitizer Nimorazole

Amrita Institute of Medical Sciences and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1)Tumour classified as stage III-IV located in oropharynx, hypopharynx and larynx according to the TNM classification.
•2) Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour.
•3) Age > 18 years and < 75 years.
•4) Informed consent according to the Helsinki declaration and institutional regulations.
•5) The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
•6) Performance status 0-2 according to WHO criteria.
•7) The patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
•8) Normal function of liver and kidney by routine laboratory examinations.
•9) The patient must not be pregnant.

•1) Distant metastases.
•2) The patient should not have any other co-morbidities or conditions that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
•3) Surgical excision (except biopsy), prior or planned (including elective neck dissection).
•4) The existence of synchronous multiple malignancies (not leucoplakia).
•5) Use of Vitamin K agonists (since 5-nitroimidazoles are inhibitors of CYP2C9).

发起方

Amrita Institute of Medical Sciences and Research