Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis

Najlaa Alyamani; Enrico Clementel; Paul Sargos; Pierre Blanchard; Stephane Supiot; Philippe Ronchin; Pascal Pommier; Thomas Duberge; Marlon Silva; Yasser Hammoud; Ali Hasbini; Jonathan Khalifa; Khemara Gnep; Christopher Scrase; Jordi Saez; Laure Vieillevigne; Melissa Christiaens; Thomas Zilli; Hélène Ribault; Alberto Bossi; Karim Fizazi; Nicolaus Andratschke

doi:10.1016/j.radonc.2025.110780

Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis

Najlaa Alyamani
, Enrico Clementel
, Paul Sargos
, Pierre Blanchard
, Stephane Supiot
, Philippe Ronchin
, Pascal Pommier
, Thomas Duberge
, Marlon Silva
, Yasser Hammoud
, Ali Hasbini
, Jonathan Khalifa
, Khemara Gnep
, Christopher Scrase
, Jordi Saez
, Laure Vieillevigne
, Melissa Christiaens
, Thomas Zilli
, Hélène Ribault
, Alberto Bossi

Karim Fizazi, Nicolaus Andratschke

North Wales Medical School

European Organisation for Research and Treatment of Cancer (EORTC) Headquarters Brussels Belgium
Department of Radiotherapy Institut Bergonie Bordeaux France
University of Paris-Saclay
Institut de Cancérologie de l'Ouest
Centre Azuréen de Cancérologie
Centre Léon Bérard
La Croix-Rouge française Centre Saint Louis
Centre François Baclesse
CHU Jean-Minjoz
CFRO-Clinique Pasteur
Oncopole Claudius Regaud
Centre Eugène Marquis
Hospital Clínic de Barcelona
Institut Claudius Regaud-Institut Universitaire du Cancer
University Hospitals Leuven
University of Geneva
UNICANCER Paris France
Institut Gustave Roussy
University Hospital Zurich University

Research output: Contribution to journal › Article › peer-review

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Abstract

PURPOSE: Radiotherapy quality assurance (RTQA) is essential for ensuring adherence to trial protocols. This paper summarizes the individual case review (ICR) results from the PEACE-1 trial, a phase-III study investigates standard of care (androgen deprivation therapy with or without docetaxel) with or without local radiotherapy; and with or without abiraterone acetate plus prednisone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

MATERIALS AND METHODS: Participating institutions submitted radiotherapy (RT) plans for central review, assessing protocol compliance in target volume and organs at risk (OARs) delineation, as well as dose specifications. ICRs were conducted either retrospectively (r-ICRs), after starting RT, or prospectively (p-ICRs), before RT initiation. Case reviews were categorized as acceptable per protocol, acceptable variation, or unacceptable variation based on delineation and dose and plan parameters.

RESULTS: Out of 585 patients in the RT arms, 527 (90%) had r-ICRs, primarily using intensity-modulated radiotherapy (IMRT). Delineation review approved 417 (87%) r-ICRs and 44 (92%) p-ICRs. The main reasons for unacceptable delineation were erroneous clinical target volume (CTV) delineation. In dose and plan reviews, 399 (96%) r-ICRs cases and 46 (96%) p-ICRs were approved, with unacceptable cases primarily due to PTV dose distribution issues.

CONCLUSION: RTQA is crucial in prostate cancer trials, primarily for proper target volume delineation. It is recommended to omit r-ICRs due to resource demands and lack of impact on RTQA outcomes, using limited p-ICRs with early feedback for site deviations and reserving full p-ICRs for trails with new techniques or dose regimens.

CLINICALTRIALS: gov: NCT01957436.

Original language	English
Article number	110780
Journal	Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
Volume	206
Early online date	7 Feb 2025
DOIs	https://doi.org/10.1016/j.radonc.2025.110780
Publication status	E-pub ahead of print - 7 Feb 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

PEACE-1
RTQA
Quality assurance
Prostate cancer

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10.1016/j.radonc.2025.110780Licence: CC BY

PIIS0167814025000751Final published version, 1.08 MBLicence: CC BY

Cite this

Alyamani, N., Clementel, E., Sargos, P., Blanchard, P., Supiot, S., Ronchin, P., Pommier, P., Duberge, T., Silva, M., Hammoud, Y., Hasbini, A., Khalifa, J., Gnep, K., Scrase, C., Saez, J., Vieillevigne, L., Christiaens, M., Zilli, T., Ribault, H., ... Andratschke, N. (2025). Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 206, Article 110780. Advance online publication. https://doi.org/10.1016/j.radonc.2025.110780

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abstract = "PURPOSE: Radiotherapy quality assurance (RTQA) is essential for ensuring adherence to trial protocols. This paper summarizes the individual case review (ICR) results from the PEACE-1 trial, a phase-III study investigates standard of care (androgen deprivation therapy with or without docetaxel) with or without local radiotherapy; and with or without abiraterone acetate plus prednisone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).MATERIALS AND METHODS: Participating institutions submitted radiotherapy (RT) plans for central review, assessing protocol compliance in target volume and organs at risk (OARs) delineation, as well as dose specifications. ICRs were conducted either retrospectively (r-ICRs), after starting RT, or prospectively (p-ICRs), before RT initiation. Case reviews were categorized as acceptable per protocol, acceptable variation, or unacceptable variation based on delineation and dose and plan parameters.RESULTS: Out of 585 patients in the RT arms, 527 (90\%) had r-ICRs, primarily using intensity-modulated radiotherapy (IMRT). Delineation review approved 417 (87\%) r-ICRs and 44 (92\%) p-ICRs. The main reasons for unacceptable delineation were erroneous clinical target volume (CTV) delineation. In dose and plan reviews, 399 (96\%) r-ICRs cases and 46 (96\%) p-ICRs were approved, with unacceptable cases primarily due to PTV dose distribution issues.CONCLUSION: RTQA is crucial in prostate cancer trials, primarily for proper target volume delineation. It is recommended to omit r-ICRs due to resource demands and lack of impact on RTQA outcomes, using limited p-ICRs with early feedback for site deviations and reserving full p-ICRs for trails with new techniques or dose regimens.CLINICALTRIALS: gov: NCT01957436.",

keywords = "PEACE-1, RTQA, Quality assurance, Prostate cancer",

author = "Najlaa Alyamani and Enrico Clementel and Paul Sargos and Pierre Blanchard and Stephane Supiot and Philippe Ronchin and Pascal Pommier and Thomas Duberge and Marlon Silva and Yasser Hammoud and Ali Hasbini and Jonathan Khalifa and Khemara Gnep and Christopher Scrase and Jordi Saez and Laure Vieillevigne and Melissa Christiaens and Thomas Zilli and H{\'e}l{\`e}ne Ribault and Alberto Bossi and Karim Fizazi and Nicolaus Andratschke",

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Alyamani, N, Clementel, E, Sargos, P, Blanchard, P, Supiot, S, Ronchin, P, Pommier, P, Duberge, T, Silva, M, Hammoud, Y, Hasbini, A, Khalifa, J, Gnep, K, Scrase, C, Saez, J, Vieillevigne, L, Christiaens, M, Zilli, T, Ribault, H, Bossi, A, Fizazi, K & Andratschke, N 2025, 'Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis', Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, vol. 206, 110780. https://doi.org/10.1016/j.radonc.2025.110780

TY - JOUR

T1 - Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis

AU - Alyamani, Najlaa

AU - Clementel, Enrico

AU - Sargos, Paul

AU - Blanchard, Pierre

AU - Supiot, Stephane

AU - Ronchin, Philippe

AU - Pommier, Pascal

AU - Duberge, Thomas

AU - Silva, Marlon

AU - Hammoud, Yasser

AU - Hasbini, Ali

AU - Khalifa, Jonathan

AU - Gnep, Khemara

AU - Scrase, Christopher

AU - Saez, Jordi

AU - Vieillevigne, Laure

AU - Christiaens, Melissa

AU - Zilli, Thomas

AU - Ribault, Hélène

AU - Bossi, Alberto

AU - Fizazi, Karim

AU - Andratschke, Nicolaus

PY - 2025/2/7

Y1 - 2025/2/7

N2 - PURPOSE: Radiotherapy quality assurance (RTQA) is essential for ensuring adherence to trial protocols. This paper summarizes the individual case review (ICR) results from the PEACE-1 trial, a phase-III study investigates standard of care (androgen deprivation therapy with or without docetaxel) with or without local radiotherapy; and with or without abiraterone acetate plus prednisone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).MATERIALS AND METHODS: Participating institutions submitted radiotherapy (RT) plans for central review, assessing protocol compliance in target volume and organs at risk (OARs) delineation, as well as dose specifications. ICRs were conducted either retrospectively (r-ICRs), after starting RT, or prospectively (p-ICRs), before RT initiation. Case reviews were categorized as acceptable per protocol, acceptable variation, or unacceptable variation based on delineation and dose and plan parameters.RESULTS: Out of 585 patients in the RT arms, 527 (90%) had r-ICRs, primarily using intensity-modulated radiotherapy (IMRT). Delineation review approved 417 (87%) r-ICRs and 44 (92%) p-ICRs. The main reasons for unacceptable delineation were erroneous clinical target volume (CTV) delineation. In dose and plan reviews, 399 (96%) r-ICRs cases and 46 (96%) p-ICRs were approved, with unacceptable cases primarily due to PTV dose distribution issues.CONCLUSION: RTQA is crucial in prostate cancer trials, primarily for proper target volume delineation. It is recommended to omit r-ICRs due to resource demands and lack of impact on RTQA outcomes, using limited p-ICRs with early feedback for site deviations and reserving full p-ICRs for trails with new techniques or dose regimens.CLINICALTRIALS: gov: NCT01957436.

AB - PURPOSE: Radiotherapy quality assurance (RTQA) is essential for ensuring adherence to trial protocols. This paper summarizes the individual case review (ICR) results from the PEACE-1 trial, a phase-III study investigates standard of care (androgen deprivation therapy with or without docetaxel) with or without local radiotherapy; and with or without abiraterone acetate plus prednisone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).MATERIALS AND METHODS: Participating institutions submitted radiotherapy (RT) plans for central review, assessing protocol compliance in target volume and organs at risk (OARs) delineation, as well as dose specifications. ICRs were conducted either retrospectively (r-ICRs), after starting RT, or prospectively (p-ICRs), before RT initiation. Case reviews were categorized as acceptable per protocol, acceptable variation, or unacceptable variation based on delineation and dose and plan parameters.RESULTS: Out of 585 patients in the RT arms, 527 (90%) had r-ICRs, primarily using intensity-modulated radiotherapy (IMRT). Delineation review approved 417 (87%) r-ICRs and 44 (92%) p-ICRs. The main reasons for unacceptable delineation were erroneous clinical target volume (CTV) delineation. In dose and plan reviews, 399 (96%) r-ICRs cases and 46 (96%) p-ICRs were approved, with unacceptable cases primarily due to PTV dose distribution issues.CONCLUSION: RTQA is crucial in prostate cancer trials, primarily for proper target volume delineation. It is recommended to omit r-ICRs due to resource demands and lack of impact on RTQA outcomes, using limited p-ICRs with early feedback for site deviations and reserving full p-ICRs for trails with new techniques or dose regimens.CLINICALTRIALS: gov: NCT01957436.

KW - PEACE-1

KW - RTQA

KW - Quality assurance

KW - Prostate cancer

U2 - 10.1016/j.radonc.2025.110780

DO - 10.1016/j.radonc.2025.110780

M3 - Article

C2 - 39924002

SN - 1879-0887

VL - 206

JO - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

JF - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

M1 - 110780

ER -

Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis

Abstract

UN SDGs

Keywords

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