What this Trial Is About

Researchers are evaluating a phase II randomized study called DE-HyART, which investigates the effect of increasing radiation doses targeted to low-oxygen (hypoxic) areas within head and neck squamous cell carcinoma tumors. This trial focuses on cancers originating from the oral cavity, oropharynx, larynx, and hypopharynx. The goal is to assess locoregional control of the cancer, the feasibility of this treatment strategy, and its acceptable toxicity. Participants are divided based on the presence of tumor hypoxia detected by an [18F] FMISO PET scan. Those without tumor hypoxia form an external cohort (Arm 1). Patients with hypoxia are randomized into two groups: Arm 2 receives standard chemoradiation with intensity-modulated radiation therapy (IMRT) plus weekly cisplatin chemotherapy, while Arm 3 receives the same treatment plus an extra 10 Gy dose targeted to the hypoxic sub-volume plus a 5mm margin. Radiation treatments are delivered using sequential planning, with doses totaling 70 Gy for standard treatment and up to 80 Gy for the dose-escalated arm, given over several weeks. Participants undergo baseline and mid-treatment [18F] FMISO scans to identify and adjust treatment to hypoxic tumor areas. Assessments include clinical evaluations, imaging, and blood tests to monitor treatment effects and safety. The primary outcome measured is locoregional cancer control at 24 months. The study includes safety and feasibility monitoring throughout treatment and follow-up, with total participation lasting several months.

Dose Escalation Using Hypoxia-adjusted Radiotherapy