Induction chemotherapy followed by chemoradiation with cetuximab and cisplatin for inoperable squamous cell carcinoma of the head and neck.

Institute of Oncology Ljubljana0 个研究点开始时间: 2007年8月31日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Squamous cell carcinoma, histologically proven.
•- Tumor site: oral cavity, oropharynx, hypopharynx, or larynx.
•- Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb), without distant metastases (M0-stage); criteria for inoperability:
•--> Technical unresectability,
•--> Tumor fixation to the clavicle, base of skull or the cervical vertebrae,
•--> Involvement of the nasopharynx or carotid artery.
•- Declaration of the inoperability of the patient given by a head and neck surgeon and radiation oncologist at the multidisciplinary tumor conference.
•- Male or female =18 years of age.
•- Expected survival > 6 months.
•- Presence of at least one bidimensionally measurable index lesion.
•- Effective contraception for both male and female subjects if risk of conception exists.
•- WHO performance status 0-2
•- Laboratory parameters:
•--> hemoglobin =100 g/L
•--> leukocyte count > 3,5×109/L, absolute neutrophil count =1,5×109/L
•--> platelet count > 100×109/L
•--> total bilirubin < 1,25×upper normal limit
•--> transaminases (ALT, AST) < 5×upper normal limit
•--> creatinine clearance =55 ml/minute.
•- Signed written informed consent.
•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.
•- Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses.
•- ChT or XRT ineligibility:
•--> Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT;
•--> Clinically evident hearing impairment;
•--> Pre-existing motor or sensory neurotoxicity grade = 2 according to the CTCAE v3.0.
•- Any kind of previous therpay for SCCHN (excluding diagnostic biopsy).
•- Previous administration of EGFR pathway-tergeting therapy.
•- 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.
•- Pregnancy or breast feeding.
•- History of severe acute pulmonary disease.
•- Any investigational agent within past 30 days.
•- Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal call carcinoma of the skin or pre-invasive carcinoma of the cervix.
•- Known drug abuse / severe alcohol 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.
•- Active, uncontrolled infection.
•- Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT.

发起方