‘Effect Of COX-2 and EGFR Suppression On Molecular Markers Of Angiogenesis And Proliferation In Squamous Cell Carcinoma Of Oral Cavity – A Prospective Randomized Study’. - E-Xib study

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•Patients must be at least 18 years of age.
•2. All patients must sign an informed consent before enrolling in study.
•3. Patients must be able and willing to return to the clinic at appropriately scheduled intervals.
•4. No use of systemic steroids or topical oral steroid preparations within three months. (Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders are allowed).
•5. Karnofsky Performance Score above 80.
•6. The subject is willing and able to fully participate for the duration of thestudy.
•7. If applicable, the subject has been counseled on smoking cessation.
•8. The subject meets the following laboratory eligibility criteria during a time not to exceed 4 weeks prior to randomization.
•? Hemoglobin level above 10gm/dl, the lower limit of normal.
•? WBC count > 3,000 mm3.
•? Platelets count > 100,000 m3.
•? Total bilirubin, AST (SGOT) and ALT (SGPT) 2 x ULN.
•Serum creatinine_ 2 x ULN.

•History of cardiovascular co morbidities.
•2. Patients with previous history of head and neck cancers.
•3. Recent massive gastrointestinal hemorrhage.
•4. An on-going unmanaged serious infectious disease or major metabolic disorder.
•5. Bilirubin at 1.5-fold above the upper limit of normal, and Kidney failure (Glomerular filtration rate of 40 mL/min).
•6. Pregnant women.
•7. Use other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids within 2 weeks prior to initial clinical evaluation.
•8. The subject is, in the op inion of the Institutional Principal Investigator, not an appropriate candidate for study participation

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