CTRI/2018/02/011824尚未招募1 期
A study to evaluate the role of pantoprazole in advanced head and neck cancers Pantoprazole in the Treatment of Head And Neck cancer - PanTHeA
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age > 18 years
- •2.Eastern Cooperative Oncology Group (ECOG) performance status 0-2 [47]
- •3.Histologically or cytologically proven squamous cell carcinoma
- •4.Primary tumor originating in the oral cavity, oropharynx, hypopharynx, larynx or metastatic cervical lymphadenopathy of unknown primary
- •5.Planned for palliative intent chemotherapy
- •6.Not planned for cetuximab-based therapy
- •7.Normal pre-treatment hematological and biochemical parameters:
- •a.Adequate bone marrow function (hemoglobin > 8 g/L, platelets > 80 x 109/L, absolute neutrophil count > 1.5 x 109/L)
- •b.Adequate liver function (ALT/AST < 2.5 x upper limit of normal [ULN], serum bilirubin < 2 x ULN), unless secondary to Gilbertâ??s disease
- •c.Adequate renal function (creatinine clearance > 45 ml/min)
- •8.Absence of uncontrolled medical comorbidity.
- •9.Willing and able to comply with all study requirements, including treatment (able to swallow tablets or the presence of a feeding tube) and able to follow up at regular intervals.
- •10.Signed, written informed consent
排除标准
- •1.Thyroid, nasopharynx or salivary gland primary.
- •2.Patient has received prior palliative intent chemotherapy for HNSCC.
- •3.Known hypersensitivity to pantoprazole
- •4.Contraindications to methotrexate or cisplatin chemotherapy
- •5.QTc prolongation (QTc prolonged more than 450 millisecond)
- •6.Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known hepatitis B or C infection will be allowed to participate provided that evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
- •7.Concurrent major illness that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
- •8.Presence of any psychological, familial, social or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
- •9.Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or agreeable to use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to enrollment. Men should either be surgically sterilized or agreeable touse a barrier method of contraception.
- •10.Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable.
- •11.Patients on other investigational drugs within the last 30 days
研究者
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