Phase I/II-study of hyperfractionated-accelerated radiation therapy (HART) plus cetuximab (CET) plus cisplatin (CIS) chemotherapy in locally advanced inoperable squamous cell cancers of head and neck. - HART-CIS-CET in SCCH

Martin-Luther-Universität Halle-Wittenberg0 个研究点目标入组 86 人开始时间: 2005年3月16日最近更新: 2016年7月4日

适应症

试验速览

暂无简介。

•Patients with histologically confirmed unresectable SCC of the oral cavity (no lip), oropharynx, hypopharynx or larynx (stage III/IVa or b)
•Unidimensionally measurable lesion
•Signed informed consent
•Karnofsky PS = 70%
•Age = 18 and = 70
•Curative treatment intent
•Negative serum or urine pregnancy test (women of childbearing potential)
•Adaequate bone marrow, hepatic and renal function
•(for further details see section 5 study protocol)
•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 86
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 86

•Unknown primary cancer, nasopharynx cancer or salivary gland cancer
•Metastatic disease
•Another cancer within 5 years of study entry
•Serious concomitant disease or medical condition
•Pregnancy or lactation
•Women of child-bearing potential with unclear contraception
•Previous treatment with chemotherapy, radiotherapy or surgery in head and neck
•Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
•Life expectancy < 3 months
•Contraindications to receive cisplatin or cetuximab
•Previous exposure to monoclonal antibodies and/or EGFR-targeted therapy
•Social situations that limit the compliance with study requirements
•(for further details see section 5 study protocol)

发起方