This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF
induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by
radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region
(oro-hypopharynx carcinoma, cancer of the oral cavity).
The primary objective of the study is to assess the feasibility of an experimental
'fractionated' TPF regimen compared to a current standard TPF regimen.
Composite endpoint of compliance and feasibility in terms of
- response (RECIST1.1) and
- hematological acute toxicity (CTCAE v.4.02)
- on time application of RAT following an experimental or standard TPF IC.
Secondary endpoints are
- Treatment intensity achieved
- Toxicity (according to CTCAE v.4.02)
- Response rates after completion of induction chemotherapy and after completion of entire
protocol treatment (RECIST1.1)
- Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after
randomisation
- Quality of life according to EORTC QoL C30 & HN35
The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients in
total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN.
Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together
with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.