eoadjuvant afatinib based treatment strategies followed by surgery in squamous cell carcinoma of the head and neck: an EORTC NOCI-HNCG window study.

Phase 1

• Conditions: Squamous cell carcinoma of the head and neck (SCCHN); MedDRA version: 15.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005820-17-IT
• Lead Sponsor: E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-12
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Newly diagnosed histologically proven squamous cell carcinoma of the oral cavity; oropharynx; hypopharynx or larynx.
•Patients selected for a primary surgical treatment.
•Performance status ECOG 0-1
Within 2 weeks prior to randomiwation:
•Adequate bone marrow function
•Adequate hepatic function times ULN
•Adequate renal function as demonstrated by serum creatinine
•Controlled blood pressure
•Adequate cardiac function
•FDG PET/CT
•DCE MRI and DWI MRI performed
•Primary tumor =2 cm in their largest diameter measured bidimensionally by imaging done within 2 weeks prior to randomization
•Availability of tumor and normal mucosa biopsies during staging endoscopy (please refer to surgical guidelines for further information)
•Availability of blood samples for Translational research
•Age =18 years
•Negative pregnancy test
•Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Patients with nasopharynx, nasal cavity and paranasal sinuses carcinomas, or recurrent/metastatic SCCHN
•T3-T4 hypopharyngeal SCCHN
•No distant metastasis
•Active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix
•Prior chemotherapy, radiotherapy or targeted therapy including HER inhibitors (monoclonal antibodies or tyrosine kinase inhibitors) for SCCHN
•No concomitant use of Potent P-gp inhibitors, Potent P-gp inducers, Erythropoietin (EPO)
•No evidence of diabetes
•No evidence of interstitial lung disease
•No weight loss of more than 10% in the previous 6 months
•Serious underlying medical conditions which could impair the ability of the patient to participate in the study
•Participation in another interventional clinical trial in the preceding 30 days prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified