Patient with locally advanced non-resectable squamous cell carcinoma of the head and neck stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Pharmaceutical Form: Intravenous infusion
Sponsors
Radiumhemmet, Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous cell carcinoma of the head and neck - stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable. Patients must have evaluable and/or measureable disease Age =18 years Performance status (WHO) of 0-1. Patient must have a life expectancy of at least 3 months allowing adequate follow-up of toxicity evaluation. Previously untreated with chemo-, immuno- or radiotherapy Adequate hematological function defined as WBC =3 x 109/litre and platelets =100 x 109litre, ANC ³1.5 x 109litre and HB > 100 g/L Adequate renal function defined as creatinine clearence = 50 ml/min Written informed consent must be obtained according to the local Ethics Committee requirements. 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
Exclusion criteria
Exclusion criteria: Patient with distant metastatic disease Oral stage I-II, oropharyngeal ca T1-T2 or N0-N1, nasopharyngeal, lipcancer, glottic ca stage I-II and cancer of the paranasal sinuses. Previous or some other concomitant malignancy, less than 5 years, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer Inability to follow the treatment and evaluation schedule Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient of interfere with the study objectives Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth-control Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment Known hypersensitivity to any of the components of the treatment Pre-existing history of severe lung disease Legal incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Locoregional tumour control 1 year;Secondary Objective: Overall survival response after induction chemotherapy overall response rate to avaluate safety and toxicity of the treatment to assess quality of life outcome in relation to molecular protein and genetic factors;Primary end point(s): Clinical benefit (CR or, PR or SD) after 12 months. | — |
Countries
Sweden
Outcome results
None listed