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Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer.

Authors :
Friborg, J.
Jensen, K.
Eriksen, J.G.
Samsøe, E.
Maare, C.
Farhadi, M.
Sibolt, P.
Nielsen, M.
Andersen, M.
Holm, A.I.S.
Skyt, P.
Smulders, B.
Johansen, J.
Overgaard, J.
Grau, C.
Hansen, C.R.
Source :
Radiotherapy & Oncology. Jan2024, Vol. 190, pN.PAG-N.PAG. 1p.
Publication Year :
2024

Abstract

• There is limited clinical data on proton radiotherapy in head and neck cancer patients. • There is no consensus on trial design or relevant endpoints. • The Danish Head and Neck Cancer Group (DAHANCA) have initiated a randomised study in an enriched population of patients with an expected benefit of protons on late toxicity. 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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01678140
Volume :
190
Database :
Academic Search Index
Journal :
Radiotherapy & Oncology
Publication Type :
Academic Journal
Accession number :
175498645
Full Text :
https://doi.org/10.1016/j.radonc.2023.109958