Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer

Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy

Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).

Inclusion Criteria:

• histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
• measurabel disease by CT and/or MRT and/or FDG-PET-CT
• fit for chemotherapy
• no prior radiotherapy or major surgery in the head/neck region
• Karnofsky Index > 60%
• informed consent

Exclusion Criteria:

• uncontrolled secondary cancer
• distant metastases
• pregnancy
• expected malcompliance