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

J. Friborg; K. Jensen; J. G. Eriksen; E. Samsøe; C. Maare; M. Farhadi; P. Sibolt; M. Nielsen; M. Andersen; A. I. S. Holm; P. Skyt; B. Smulders; J. Johansen; J. Overgaard; C. Grau; C. R. Hansen

doi:10.1016/j.radonc.2023.109958

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

J. Friborg^*, K. Jensen, J. G. Eriksen, E. Samsøe, C. Maare, M. Farhadi, P. Sibolt, M. Nielsen, M. Andersen, A. I. S. Holm, P. Skyt, B. Smulders, J. Johansen, J. Overgaard, C. Grau, C. R. Hansen

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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.

Originalsprog	Engelsk
Artikelnummer	109958
Tidsskrift	Radiotherapy & Oncology
Vol/bind	190
Antal sider	7
ISSN	0167-8140
DOI	https://doi.org/10.1016/j.radonc.2023.109958
Status	Udgivet - jan. 2024

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10.1016/j.radonc.2023.109958Licens: CC BY 4.0

Friborg et al. (2024). Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancerForlagets udgivne version, 1,46 MBLicens: CC BY 4.0

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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. (2024). Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer. Radiotherapy & Oncology, 190, Artikel 109958. https://doi.org/10.1016/j.radonc.2023.109958

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title = "Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer",

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.",

keywords = "Head and neck cancer, Proton radiotherapy, Trial design",

author = "J. Friborg and K. Jensen and Eriksen, {J. G.} and E. Sams{\o}e and C. Maare and M. Farhadi and P. Sibolt and M. Nielsen and M. Andersen and Holm, {A. I. S.} and P. Skyt and B. Smulders and J. Johansen and J. Overgaard and C. Grau and Hansen, {C. R.}",

note = "Copyright {\textcopyright} 2023. Published by Elsevier B.V.",

year = "2024",

month = jan,

doi = "10.1016/j.radonc.2023.109958",

language = "English",

volume = "190",

journal = "Radiotherapy & Oncology",

issn = "0167-8140",

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Friborg, J, Jensen, K, Eriksen, JG, Samsøe, E, Maare, C, Farhadi, M, Sibolt, P, Nielsen, M , Andersen, M, Holm, AIS, Skyt, P, Smulders, B, Johansen, J, Overgaard, J, Grau, C & Hansen, CR 2024, 'Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer', Radiotherapy & Oncology, bind 190, 109958. https://doi.org/10.1016/j.radonc.2023.109958

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T1 - Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer

AU - Friborg, J.

AU - Jensen, K.

AU - Eriksen, J. G.

AU - Samsøe, E.

AU - Maare, C.

AU - Farhadi, M.

AU - Sibolt, P.

AU - Nielsen, M.

AU - Andersen, M.

AU - Holm, A. I. S.

AU - Skyt, P.

AU - Smulders, B.

AU - Johansen, J.

AU - Overgaard, J.

AU - Grau, C.

AU - Hansen, C. R.

PY - 2024/1

Y1 - 2024/1

N2 - 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.

AB - 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.

KW - Head and neck cancer

KW - Proton radiotherapy

KW - Trial design

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U2 - 10.1016/j.radonc.2023.109958

DO - 10.1016/j.radonc.2023.109958

M3 - Journal article

C2 - 37871751

SN - 0167-8140

VL - 190

JO - Radiotherapy & Oncology

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

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