Hautveränderungen bei Patienten mit Kopf- und Halstumor unter kombinierter RadioImmuno-(chemo)-therapie mit Erbitux® - HICARE-Trial

niversity of Heidelberg0 个研究点开始时间: 2010年9月29日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•- Histologically confirmed, locally advanced (stage III, IVA or IVB) non-metastatic squamous-cell carcinoma of the oral cavity, oro- or hypopharynx and larynx
•- ECOG Performance Status of 0-2
•- = 18 years of age
•- Life expectancy of at least 6 months.
•- Adequate bone marrow, liver and renal function (according to SmPC of Cetuximab) based on laboratory assessments raised within 7 days prior to start of study treatment.
•- Signed and dated informed consent before the start of specific protocol procedures.
•- Women of childbearing potential must have had a negative serum or urine beta-HCG pregnancy test within 7 days prior to the first administration of study treatment or must have a documented condition that prohibits pregnancy (e.g. post-menopausal; hysterectomy).
•- Patients enrolled in this trial must be willing to use effective birth control measures during the course of the trial and the subsequent 2 months
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•- Nasopharyngeal carcinoma
•- Distant metastases
•- Previous radiotherapy for carcinoma of the head and neck
•- Participation in other clinical trial (according to the German Drug Law (Arzneimittelgesetz - AMG) within 30 days prior to start of study treatment
•- Previous exposure to epidermal growth factor (EGFR) targeted therapy
•- Known hypersensitive reaction to any of the components of study treatments
•- Previous or concurrent cancer within 5 years prior to study entry that is distinct in primary site or histology except adequately treated basal cell carcinoma or preinvasive cervical carcinoma.
•- Pregnant or breast-feeding patients
•- Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results as judged by the investigator
•- Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
•- Incapacity to consent or limited capacity to consent

发起方

niversity of Heidelberg