head and neck carcinoma laryngeal cancer
Conditions
Interventions
induction chemotherapy with TPF followed by chemoradiation with weekly
cisplatin or carboplatin in combination with Cetuximab. Randomisation to
cisplatin or carboplatin.
Sponsors
EORTC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically proven newly diagnosed unresectable squamous cell carcinoma of the head and neck. -Patients who have uni- or bidimensionally measurable disease. - Patients must consent to access of their skin material for EGFR status and downstream signaling. - Stage III or IV. - Absence of distant metastasis - Patients who have unresectable disease - No prior treatment for head and neck cancer - No nasopharynx, nasal and paranasal cancer - Age 18-75 - WHO Performance Status 0 or 1 - Normal hematological functions: neutrophils * 1.5 x109 cells/l, platelets * 100 x109 cells/l. - Normal liver functions: bilirubin
Exclusion criteria
Exclusion criteria: see above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be to determine the feasibility of regimens assessed on at least 80% of the per protocol dose intensity of the radiotherapy, the platinum and cetuximab during the chemo-radiation part of treatment. If delays and/or dose reductions lead to less than 80% dose intensity for at least one of these three treatments, the patient will be counted as a failure for this criterion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be toxicity, dose modifications, response rate. Safety Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 | — |
Countries
Netherlands
Outcome results
None listed