Preirradiated patients with locally recurrent or with secondary squamous cell carcinoma of the head and neck MedDRA version: 12.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Conditions
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Lübeck: Klinik für Strahlentherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility rate of cetuximab in combination with re-irradiation;Secondary Objective: • Locoregional control rate • Time to progression • Overall survival • Quality of life (EORTC QLQ C-30/QLQ-H&N35) • To determine the overall response rate • Safety and toxicity ;Primary end point(s): Feasibility rate of cetuximab in combination with re-irradiation. | — |
Countries
Germany
Outcome results
None listed