Analysis of genetic host factors, HPV, EGFR and Hypoxia markers and theirassociation with outcome in laryngeal and pharyngeal cancers

tata Memorial Centre0 个研究点目标入组 536 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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•ï??Histologically confirmed Squamous Cell Carcinoma of Head and Neck in advanced stage [stage III or IVA, B)] considered to be suitable for concurrent chemoradiotherapy.
•ï?? Written informed consent has been obtained
•ï??Karnofsky Performance Status (KPS) > 70
•ï??Adults of either sex, between 18 years and above with a life expectancy of at least 6 months.
•ï??Adequate hematologic function (Absolute Neutrophil Count (ANC) >= 1,500 cells/ÂµL; Hemoglobin > 9 g/dL, platelets > 100,000/ÂµL and <= 500,000/ÂµL)
•ï??Adequate renal function (serum creatinine <= 1.5 mg/dL or calculated creatinine clearance >= 45 ml/min)
•ï??Adequate hepatic function [bilirubin <= 1.5 x ULN (upper limit of normal), alanine amino transferase (ALT) <= 5 x ULN, aspartate amino transferase (AST) <= 5 x ULN]
•ï??Female patients must have a negative urine pregnancy test at pre-study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
•ï??All patients of reproductive potential must agree to use an approved form of contraception

•ï??Nasopharyngeal, salivary glands, nasal cavities, maxillary sinus, paranasal sinus squamous cell carcinoma
•ï??Patients with a history of prior malignancy other than non-melanoma skin cancer or cervical cancer in-situ
•ï??Patients who have had immunotherapy
•ï??Patients who have received radiotherapy to head & neck
•ï??Known or suspected hypersensitivity to compounds with similarity to BIOMAb EGFR for eg. trastuzumab.
•ï??Patients with distant metastases
•ï??Pregnant or lactating women
•ï??Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
•ï??Known infection with HIV or Active viral hepatitis
•ï??Prior therapy that specifically and directly targets the EGFR pathway

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