Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2025
Comprehensive radiotherapy quality assurance analysis from individual DICOM data in the HypoG-01 phase 3 trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Brion Thomas, Balde Mamadou, Allodji Rodrigue, Rossier Christine, Auzac Guillaume, Petit Claire, Maroun Pierre, Ruffier Amandine, Pasquier David, Wong Stephanie, Lamrani Assia, Bergeaud Marie, Dequeker Guenael, Ducornet Sandrine, Ghodssighassemabadi Robabeh, Michiels Stefan, Rivera Sofia, HypoG-01 trialists
Аннотация
PURPOSE: Quality Assurance (QA) in radiation therapy (RT) trials is crucial. We report here the QA analysis of prospectively collected individual RT-plans in the HypoG-01 phase III trial.
METHODS: HypoG-01 randomised breast cancer patients indicated for locoregional RT to 40 Gy/15 fractions/3 weeks versus 50 Gy/25 fractions/5 weeks. Volume definitions following ESTRO guidelines, and dosimetric constraints were predefined. All centres underwent a prospective QA, including systematic DICOM-RT transfer. Descriptive analyses of protocol compliance, and intra and inter-centre variations were conducted.
RESULTS: RT-plans from 1,093 patients (89.5% of the per-protocol population), included between September 2016 and March 2020, were retrieved from 29 centres. Overall, 610 patients underwent breast-conservation surgery, with 541 receiving a tumour-bed boost, either sequentially (69.9%) or simultaneously (30.1%). Only 76 patients (6.9%) were treated using breath-hold. Most plans (99.2%) had compliant prescribed doses. Delineation rates of pre-specified organs at risk ranged from 95.2% and 100%. Regarding treatment planning, 75.1% of the CTVp_breast, 42.9% of the CTVp_thoracic wall, 90.4% of the CTVp_tumour bed, and 67.5-87.7% of the CTVn complied with protocol constraints. For delineated OARs, constraints were met in 93.7% for heart, 81.2% for ipsilateral lung, and 63.4% for contralateral breast without obvious differences between arms; however, large intra and inter-centre variability was noted.
CONCLUSION: The observed heterogeneity in contouring and RT-planning highlights the need for rigorous QA. Our QA analysis finds comparable results in both arms, which confirms the robustness of HypoG-01 outcomes, and offers a scalable framework for the conduct of future RT trials.
METHODS: HypoG-01 randomised breast cancer patients indicated for locoregional RT to 40 Gy/15 fractions/3 weeks versus 50 Gy/25 fractions/5 weeks. Volume definitions following ESTRO guidelines, and dosimetric constraints were predefined. All centres underwent a prospective QA, including systematic DICOM-RT transfer. Descriptive analyses of protocol compliance, and intra and inter-centre variations were conducted.
RESULTS: RT-plans from 1,093 patients (89.5% of the per-protocol population), included between September 2016 and March 2020, were retrieved from 29 centres. Overall, 610 patients underwent breast-conservation surgery, with 541 receiving a tumour-bed boost, either sequentially (69.9%) or simultaneously (30.1%). Only 76 patients (6.9%) were treated using breath-hold. Most plans (99.2%) had compliant prescribed doses. Delineation rates of pre-specified organs at risk ranged from 95.2% and 100%. Regarding treatment planning, 75.1% of the CTVp_breast, 42.9% of the CTVp_thoracic wall, 90.4% of the CTVp_tumour bed, and 67.5-87.7% of the CTVn complied with protocol constraints. For delineated OARs, constraints were met in 93.7% for heart, 81.2% for ipsilateral lung, and 63.4% for contralateral breast without obvious differences between arms; however, large intra and inter-centre variability was noted.
CONCLUSION: The observed heterogeneity in contouring and RT-planning highlights the need for rigorous QA. Our QA analysis finds comparable results in both arms, which confirms the robustness of HypoG-01 outcomes, and offers a scalable framework for the conduct of future RT trials.