A randomized study for evaluation of metronomic adjuvant chemotherapy in recurrent head and neck cancers post R0 salvage surgical resection who are ineligible for re-irradiation.

Tata Memorial Hospital0 个研究点目标入组 400 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.Patients with recurrenthead and neck cancers with primary in oral cavity, oropharynx, larynx or hypopharynx who have undergone complete salvage resection ( R0 resection)
•2.Ineligibile for re-irradiation in target region after assesement in joint clinic.
•3.Age >=18 years
•4.ECOG performance status PS 0-2
•5.Adequate bone marrow function (Haemoglobin > 8 0g/L, platelets > 100 x 109/L, ANC > 1.5 x 109/L)
•6.Adequate liver function (ALT/AST < 1.5 x ULN, serum bilirubin < 2mg/dl)
•7.Adequate renal function (creatinine clearance > 50 ml/min)
•8.Adequate cardiac function (LVEF >40%)
•9.Study treatment both planned and able to start within 28 days of enrollment
•10.Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. able to have IV contrast if this is required for tumour assessments)
•11.Signed, written informed consent for main study and tissue banking.

•1.QTc prolongation (QTc B prolonged more than 450 millisecond)
•2.Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. for these is not mandatory unless clinically indicated. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
•3.Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety; Serious medical (e.g. Diabetes Mellitus, Hypertension, COPD ,active Tuberculosis or 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 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 use a (double if required) barrier method of contraception.

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