NCT01538381

Neoadjuvant Afatinib Window Study in Squamous Cell Carcinoma of the Head and Neck

Neoadjuvant Afatinib Based Treatment Strategies Followed by Surgery in Squamous Cell Carcinoma of the Head and Neck: an EORTC NOCI-HNCG Window Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The general objectives are to evaluate the pre-operative activity and the safety of afatinib in head and neck cancer and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms. The results from this study can be used to conduct a larger trial that would allow us to confirm or validate the hypotheses generated.

Detailed description

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 treatment' arm. 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 afatinib arm. 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.

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
DRUG	Afatinib	Afatinib for 2 weeks at a dose of 40 mg/day
OTHER	Observation	Observation

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2012-02-24
• Last updated: 2018-07-09

Locations

4 sites across 2 countries: Belgium, Italy