Open, uncontrolled, non-commercial Clinical Trial of induction chemotherapy with Cetuximab, Docetaxel, Cisplatin, 5FU followed by Cetuximab + radiotherapy in the responders in locally advanced resectable SCCH

ational Institute of Oncology0 个研究点开始时间: 2007年7月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Signed written informed consent
•- Male or female >18 years of age
•- Newly diagnosed, histologically confirmed squamous cell carcinoma of the oral cavity,oropharynx, hypopharynx or larynx; locally advanced, resectable disease
•- Presence of at least one bidimensionally measurable index lesion
•- Declaration of two independent head and neck surgeons in the context of a multidisciplinary tumor conference on the operability of the patient, and description of planned type of surgery in case if the patient will be non-responder
•- Written declaration of the patient, that he/she prefers primary non surgical treatment after detailed information concerning both treatment modalities, procedures and consequences
•- Karnofsky Performance Status = 80 at study entry
•- Effective contraception for both male and female subjects if risk of conception exists
•- Bilirubin level = 1.5 x ULN
•- AST and/or ALT = 2.5 x ULN
•- Serum creatinine =1.5 x ULN
•- Leukocytes count = 3 x 109/L, neutrophils = 1.5 x109/L, platelets > 100 x 109/L, and hemoglobin > 9 g/dL
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Metastatic disease
•- Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)
•- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol
•- Participation in another clinical trial within 30 days prior to study entry
•- Previous administration of EGFR pathway-targeting therapy
•- Clinically relevant coronary artery disease, history of myocardial infarction within the last 6 months, or high risk/uncontrolled arrhythmia
•- Known grade 3 or 4 allergic reaction to any of the components of the treatment
•- Pregnancy (absence confirmed by serum/urine HCG in premenopausal women) or breast-feeding
•- History of severe pulmonary disease
•- Any investigational agents within the past 30 days
•- Having previously participated in a study which included the possibility of being allocated to cetuximab therapy (whether or not the subject actually received cetuximab)
•- Other previous malignancies within 5 years, with exception of a history of adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
•- Known drug abuse
•- Legal incapacity or limited legal capacity
•- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent

发起方

ational Institute of Oncology