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.

Original language	English
Article number	109958
Journal	Radiotherapy & 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 Neoplasms/radiotherapy
Humans
Photons/therapeutic use
Probability
Proton Therapy/methods
Protons
Radiotherapy Dosage
Radiotherapy Planning, Computer-Assisted
Radiotherapy, Intensity-Modulated/methods

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10.1016/j.radonc.2023.109958Licence: CC BY

Open Access VersionFinal published version, 1.46 MBLicence: CC BY

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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, Article 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 Neoplasms/radiotherapy, Humans, Photons/therapeutic use, Probability, Proton Therapy/methods, Protons, Radiotherapy Dosage, Radiotherapy Planning, Computer-Assisted, Radiotherapy, Intensity-Modulated/methods",

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}",

year = "2024",

month = jan,

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

language = "English",

volume = "190",

journal = "Radiotherapy & Oncology",

issn = "0167-8140",

publisher = "Elsevier",

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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, 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, 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 Neoplasms/radiotherapy

KW - Humans

KW - Photons/therapeutic use

KW - Probability

KW - Proton Therapy/methods

KW - Protons

KW - Radiotherapy Dosage

KW - Radiotherapy Planning, Computer-Assisted

KW - Radiotherapy, Intensity-Modulated/methods

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

JF - Radiotherapy & Oncology

M1 - 109958

ER -

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

Abstract

Keywords

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