A randomized trial to compare the efficacy of docetaxel and cisplatin and docetaxel and cisplatin and 5 flurouracil(DCF) in patients as neoadjuvant chemotherapy for oral cavity cancer

Tata Memorial centre0 个研究点目标入组 492 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.Histologically or cytologically confirmed squamous cell carcinoma of age more than 18 years;
•2.Performance status <= 2 on the ECOG performance scale.
•3.There should not be any prior history of any chemotherapy.
•4.There should be at least one lesion that is measurable either unidimensionally or bidimensionally.
•5.Tumour has to considered technically unresectable by a multidisciplinary team.
•6.Estimated life expectancy of at least 12-weeks.
•7.Adequate organ and immune system function as indicated by the following laboratory values, obtained <= 3 weeks prior to dosing:
•SystemLab value
•Hematologic
•ANC>= 1.5 Ã? 109 /L
•Hb>= 8.0 g/dL
•Platelets>= 100 Ã? 109 /L
•Sr. Creatinine<= 2.0 mg/dL
•Total Bilirubin<= ULN
•AST <= 3 Ã? ULN
•ALT<= 3 Ã? ULN
•Alkaline Phosphatase<= 5 Ã? ULN
•8.Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. A man who is the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.
•9.Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals.
•10. Signed, written informed consent

•1.Clinical or radiologic evidence of metastatic disease.
•2.Any significant active infection, including chronic active hepatitis B, active hepatitis C, HIV infection with AIDS or immunodeficiency syndromes.
•3.Serious uncontrolled medical illness (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, severe infectionor untreated psychiatric conditions) that might limit the ability of the patient to comply with the protocol.
•4.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
•5.Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or willing to use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or be willing to use a (double if required) barrier method of contraception

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