Patients with non-resectable stage III-IV head and neck cancer
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
Trade Name: Cisplatin
Pharmaceutical Form: Solution for infusion
Trade Name: Fluorouracil
Pharmaceutical Form: Solution for infusion
IN
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma of the head and neck region - stage III or IV, oral, oropharyngeal, laryngeal, hypopharyngeal, , non-resectable.with known HPV+ status 2. Patients must have evaluable and/or measurable disease 3. Age =?18 years 4. Performance status (WHO) of 0-1 5. Patient must have a life expectancy of at least 3 months allowing adequate follow-up of toxicity evaluation 6. Previously untreated for Head and Neck cancer 7. Adequate hematological function defined as WBC = 3 x 109/litre and platelets = 100 x 109/litre, ANC ? 1.5 x 109/litre and Hb > 100 g/L 8. Adequate renal function defined as creatinine clearence = 50 ml/min (may be calculated using the Cockroft and Gault formula, see appendix I) 9. Adequate liver function: Bilirubin = 1, 5 x UNL, ALAT or ASAT = 3, 0 UNL, alkaline phosphatase > 2.5 UNL 10. 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: 1. Patient with distant metastatic disease 2. Oropharyngeal cancer ca T1-T2 or N0-N1, nasopharyngeal ca, lip cancer and cancer of the paranasal sinuses 3. Previous or some other concomitant malignancy since < 5 years with the exception of adequately treated basal cell skin cancer or in situ cervical cancer 4. Inability to follow the treatment and evaluation schedule 5. Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient of or interfere with the study objectives 6. Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth-control 7. Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment as for example history of severe lung disease 8. Known hypersensitivity to any of the components of the treatment. 9. Pre-existing history of severe lung disease 10. Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arythmias 11. Legal incapacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in HPV positive patients with locally advanced unresectable SCCHN whether the PFS rate in the experimental arm (radiotherapy plus cetuximab) is not markedly worse than the PFS in the control arm (TPF induction chemotherapy followed by radiotherapy plus cetuximab);Secondary Objective: To compare in HPV positive patients with locally advanced unresectable SCCHN the locoregional control rate at 2 years, overall survival, response rate, treatment failure free survival, toxicity, response rate, pattern of relapse and QoL in both treatment arms.;Primary end point(s): PFS time | — |
Countries
Sweden
Outcome results
None listed