The efficacy and safety of combined neoadjuvant chemotherapy with docetaxel, cisplatin and 5-Fluorouracil (5-FU) [TPF regimen] and concurrent chemoradiation in treating patients with locally advanced cancer of the larynx

Shiraz University of Medical Sciences0 个研究点目标入组 50 人开始时间: 2010年10月14日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Pathologically proven locally advanced laryngeal carcinoma.
•2. No prior therapy
•3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
•4. Karnofsky performance status greater than or equal to 70
•5. Written informed consent
•6. Normal or acceptable liver, kidney and bone marrow function (Absolute neutrophil count greater than or equal to 1,500/mm3
•Platelet count greater than or equal to 100,000/mm3
•Bilirubin < 1.5 times the upper limit of the normal range
•Alkaline phosphatase and transaminases < 2.5 times the upper limit of the normal range
•Serum creatinine < 1.7 mg/dL)
•Females must not be pregnant or lactating

•1. Prior therapy 2. Clinical or imaging evidence of distant metastasis 3. Patients with a known contraindication (such as allergy to taxan drugs,
•5. Patients must have
•normal cardiac function [Left ventricular ejection fraction (LVEF) assessed by Multigated radionuclide angiography (MUGA) or echocardiography (ECHO) and clinically satisfactory 12-lead electrocardiography (ECG)
•No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
•History of documented congestive heart failure
•High-risk uncontrolled arrhythmias
•Angina pectoris requiring antianginal medication
•Clinically significant valvular heart disease
•Evidence of transmural infarction on ECG
•Poorly controlled hypertension (e.g., systolic blood presure (BP) > 180 mm Hg or diastolic BP > 100 mm Hg)]
•6. Patients with severe liver, renal, inflammatory intestinal or blood coagulation disorders,

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