TY - JOUR
T1 - Radiotherapy quality assurance for the PEACE 1 trial
T2 - 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
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/5/1
Y1 - 2025/5/1
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 - Prostate cancer
KW - Quality assurance
KW - RTQA
UR - http://www.scopus.com/inward/record.url?scp=85218900860&partnerID=8YFLogxK
U2 - 10.1016/j.radonc.2025.110780
DO - 10.1016/j.radonc.2025.110780
M3 - Article
C2 - 39924002
AN - SCOPUS:85218900860
SN - 0167-8140
VL - 206
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
M1 - 110780
ER -