Re-irradiation combined with cetuximab for the treatment of patients with locally recurrent or with secondary squamous cell carcinoma of the head and neck - RECET

niversitätsklinikum Schleswig-Holstein, Campus Lübeck: Klinik für Strahlentherapie0 个研究点开始时间: 2010年5月18日最近更新: 2012年3月19日

试验速览

暂无简介。

•Signed written informed consent
•Male or female age 18 to 65 years
•Unresectable histologically confirmed squamous cell carcinoma of the larynx, hypopharynx, oropharynx or oral cavity suitable for re-irradiation and
•locally recurrent or development of a second primary tumor after radio- or radiochemotherapy
•Minimal interval of 12 months from end of prior radiotherapy
•No severe sequelae of the first course of radiotherapy
•Expected survival more than 3 months
•At least one uni-measurable lesion according to the RECIST criteria Version 1.1 must be present
•Karnofsky Performance Score = 70%
•Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL
•Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, AP, ?-GT < 3 x ULN
•Adequate renal function: serum creatinine < 1.5 mg/dL
•If of childbearing potential, willingness to use effective contraceptive methods for the study duration and 2 months post-dosing.
•No surgery or any investigational agent within 4 weeks of study entry
•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) no
•F.1.3.1 Number of subjects for this age range

•Presence of distant metastases
•Prior exposure to EGFR pathway targeting therapy
•Severe radiation dermatitis grade 4 during/after previous radiotherapy
•Other serious illness or medical conditions:
•-Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4
•-Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal
•-Significant neurologic or psychiatric disorders including dementia or seizures;
•-Active uncontrolled infection;
•-Active disseminated intravascular coagulation;
•-Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
•Having participated in another clinical trial or any investigational agent in the preceding 30 days
•Known allergic/hypersensitivity reaction to any of the components of the treatment
•Pregnancy (absence confirmed by serum/urine ?-HCG) or breast-feeding
•Known drug abuse
•Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
•Legal incapacity or limited legal capacity
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

发起方

niversitätsklinikum Schleswig-Holstein, Campus Lübeck: Klinik für Strahlentherapie