Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer
Jeppe Friborg, Kenneth Jensen, Jaran Eriksen, Eva Samsøe, Christian Maare, Mohammad Farhadi, Patrik Sibolt, Martin Skovmos Nielsen, Marianne Andersen, Åsa Holm, P.S. Skyt, Bob Smulders, Jørgen Johansen, Jens Overgaard, Cai Grau, Christian Rønn Hansen
Abstract
Proton radiotherapy offers a dosimetric advantage compared to photon therapy in sparing normal tissue, but the clinical evidence for toxicity reductions in the treatment of head and neck cancer is limited. The Danish Head and Neck Cancer Group (DAHANCA) has initiated the DAHANCA 35 randomised trial to clarify the value of proton therapy (NCT04607694). The DAHANCA 35 trial is performed in an enriched population of patients selected by an anticipated benefit of proton therapy to reduce the risk of late dysphagia or xerostomia based on normal tissue complication probability (NTCP) modelling. We present our considerations on the trial design and a test of the selection procedure conducted before initiating the randomised study.