Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.

A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.

The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
• Primary unresectable tumor and/or patients that refused surgery
• Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
• Multidisciplinary decision of curative radiotherapy or radiochemotherapy
• Karnofsky performance status >= 70 %
• Age >= 18 years old
• Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

• High risk Human Papilloma Virus (HPV)
• Treatment combined with brachytherapy
• Prior irradiation to the head and neck region
• History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
• Distant metastases
• Pregnant or lactating women
• Creatinine clearance (Cockcroft-Gault) =< 60 mL/min
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.