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

IF 4.9 1区医学 Q1 ONCOLOGY

Radiotherapy and Oncology Pub Date : 2025-02-07 DOI:10.1016/j.radonc.2025.110780

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 , Nicolaus Andratschke

{"title":"Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis","authors":"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 , Nicolaus Andratschke","doi":"10.1016/j.radonc.2025.110780","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>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).</div></div><div><h3>Materials and methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div><div>ClinicalTrials.gov: NCT01957436.</div></div>","PeriodicalId":21041,"journal":{"name":"Radiotherapy and Oncology","volume":"206 ","pages":"Article 110780"},"PeriodicalIF":4.9000,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Radiotherapy and Oncology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0167814025000751","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Radiotherapy and Oncology 医学-核医学

CiteScore

10.30

自引率

10.50%

发文量

2445

审稿时长

45 days

期刊介绍： Radiotherapy and Oncology publishes papers describing original research as well as review articles. It covers areas of interest relating to radiation oncology. This includes: clinical radiotherapy, combined modality treatment, translational studies, epidemiological outcomes, imaging, dosimetry, and radiation therapy planning, experimental work in radiobiology, chemobiology, hyperthermia and tumour biology, as well as data science in radiation oncology and physics aspects relevant to oncology.Papers on more general aspects of interest to the radiation oncologist including chemotherapy, surgery and immunology are also published.