Neoadjuvant Afatinib Based Treatment Strategies Followed by Surgery in Squamous Cell Carcinoma of the Head and Neck: an EORTC NOCI-HNCG Window Study.
This is a randomized, multicenter early phase II trial exploring the pre-operative activity
of afatinib vs. nontreatment. The study includes an early monitoring of the surgical
co-morbidities for patients treated with afatinib and accrual may be stopped prematurely
according to a pre-defined safety stopping rule.
Patients will be randomized with a 5:1 ratio, between the two arms: afatinib and 'no
treatment'. It is intended to include a total of 30 eligible patients out of which 25
patients will be randomized into the afatinib arm.
Patients allocated to the 'no treatment' arm will mainly serve as a reference to interpret
the results of the translational research part of the study although no formal comparison
between the afatinib arm and the 'no treatment' arm is intended.
Patients will be first registered into the EORTC system after signing the informed consent
form. The site will have to complete all the study related procedures within 4 weeks prior
randomization and all eligibility criteria should be met before the patient can be
randomized into the study.
The registration of patients will proceed with slots for patients which will be opened or
closed based on the randomization of patients into the afatinib arm. Starting with 3 free
slots, an additional slot will become available for each patient randomized to the 'no
Registration will be paused after three completes the 4 week observation period after
surgery. Similar action will be done after the next 3 patients have been entered into the
Once the first 6 patients in the afatinib arm have been observed for surgical toxicities of
grade ≥ 3 for 4 weeks following surgery, the slot system will cease to operate.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction of tumor Standardised Uptake Volume as assessed by FDGPET
Afatinib will be given orally for 2 weeks from the day of randomization until day -1 prior to surgery at a dose of 40 mg/day.Pre-treatment biopsies and blood samples will be harvested during the regular diagnosis staging procedure and at surgery.FDG-PET/CT-scan and MRIs will be performed before treatment (before day -15) and the day before surgery.The primary outcome measure is the reduction in the tumor standardised uptake volume as assessed by FDGPET
Baseline and after two weeks of treatment
Jean-Pascal Machiels, MD
European Organisation for Research and Treatment of Cancer - EORTC
Belgium: Federal Agency for Medicinal Products and Health Products