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; Jens 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, Jens Overgaard, C. Grau, C. R. Hansen

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Letter › peer-review

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.

Original language	English
Article number	109958
Journal	Radiotherapy and Oncology
Volume	190
ISSN	0167-8140
DOIs	https://doi.org/10.1016/j.radonc.2023.109958
Publication status	Published - Jan 2024

Keywords

Head and neck cancer
Proton radiotherapy
Trial design

Access to Document

10.1016/j.radonc.2023.109958Licence: CC BY

Cite this

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 and Oncology, 190, Article 109958. https://doi.org/10.1016/j.radonc.2023.109958

@article{0379fed64f8c428a82efe1d0a72814a6,

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 Jens Overgaard and C. Grau and Hansen, {C. R.}",

note = "Publisher Copyright: {\textcopyright} 2023",

year = "2024",

month = jan,

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

language = "English",

volume = "190",

journal = "Radiotherapy and Oncology",

issn = "0167-8140",

publisher = "Elsevier Ireland Ltd.",

}

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 and Oncology, vol. 190, 109958. https://doi.org/10.1016/j.radonc.2023.109958

TY - JOUR

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, Jens

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

U2 - 10.1016/j.radonc.2023.109958

DO - 10.1016/j.radonc.2023.109958

M3 - Letter

C2 - 37871751

AN - SCOPUS:85176078117

SN - 0167-8140

VL - 190

JO - Radiotherapy and Oncology

JF - Radiotherapy and Oncology

M1 - 109958

ER -

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

Abstract

Keywords

Access to Document

Fingerprint

Cite this