Phase II Randomized Study With Cisplatinum or Cetuximab and Standard or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
Inclusion Criteria:
- biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or
hypopharynx
- stage III/IV, T3-4, Nx M0
- < 70 yrs
- glomerular filtration rate (GFR) >60
- WHO 0-1
- no previous malignancies except for adequately treated basal cell carcinoma of the
skin and carcinoma in situ of the cervix
- adequate bone marrow function, adequate hepatic function,informed consent
- >18 years
Exclusion Criteria:
- expected failure from follow-up
- previous malignancies except for adequately treated basal cell carcinoma of the skin
and carcinoma in situ of the cervix
- expected inability to complete either one of the treatment arms
- pregnancy or lactation
- patients (m/f) with reproductive potential not implementing adequate contraceptive
measures
- prior surgery, radiotherapy or chemotherapy for this tumor
- contraindications or serious concomitant diseases preventing the safe administration
of chemotherapy and/or radiotherapy or are likely to interfere with the study
assessments
- known active symptomatic fungal, bacterial and/or viral infections including HIV
- concomitant (or with 4 weeks before randomisation) administration of any other
experimental drug
- concurrent treatment with any other anti-cancer therapy
- prior treatment with one or more of the active compounds