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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 Cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX
Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX
Hyperfractionated accelerated radiotherapy with concurrent Cisplatin and 5-Fluorouracil chemotherapy
Charité Universitaetsmedizin Berlin, CVK, CBF
Berlin, Germany
University Medical Center Hamburg - Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.
acute hematological toxicity
Time frame: August 2010- December 2012
Survival and late morbidity
All adequate items illustrating acute toxicity and late morbidity, in particular by hematological measures until one year after treatment (according to NCI-CTCAE v.4.02) Survival (progression-free, metastases-free, recurrence-free, Overall survival) after 1 year Response rates after TPF IC (RECIST1.1) Response rates after completion of multimodal treatment (see follow-up for scheduling RECIST1.1) Efficacy in relation to HPV status (p16 IHC) Quality of life according to EORTC QLC-30 \& HN35
Time frame: 1 year
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