Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx and larynx.
- Primary non-resected tumor and/or patients refused surgery
- Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
- Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary
Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
- Karnofsky performance status >= 70 %
- Age >= 18 years old
- Informed consent obtained, signed and dated before specific protocol procedures
Exclusion Criteria:
- Treatment combined with brachytherapy
- Prior irradiation to the head and neck region
- Surgery of the primary tumor except lymph node dissection prior to radiotherapy
- induction chemotherapy
- 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 at least 5 years
- Distant metastases
- Creatinine clearance (Cockroft-Gault) =< 60 milliliter/minute before treatment or
creatinine value > 1,3 milligram/deciliter
- Known allergy to the CT-contrast agents
- Pregnant or lactating women
- 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