1. Quality assurance program and early toxicities in the phase III BONBIS randomized trial evaluating the role of a localized radiation boost in ductal carcinoma in situ
- Author
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Stephen Ellis, Alice Mege, D. Cowen, David Azria, Julien Geffrelot, Christel Breton-Callu, P. Fenoglietto, I. Latorzeff, A. Benyoucef, Sofia Rivera, K. Peignaux, Stephane Jacquot, Florence Castan, Yazid Belkacemi, A. Labib, Carole Massabeau, Sophie Gourgou, Fatiha Boulbair, Françoise Bons, C. Lemanski, Philippe Guilbert, Ulrike Schick, I. Lecouillard, Zineb Douadi-Gaci, Jacques Cretin, Séverine Racadot, Agnès Richard-Tallet, Magali Le Blanc-Onfroy, and Céline Bourgier
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Planning target volume ,Breast Neoplasms ,law.invention ,Randomized controlled trial ,law ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Breast ,business.industry ,Radiotherapy Planning, Computer-Assisted ,BREAST ERYTHEMA ,Hypertrophy ,Hematology ,Ductal carcinoma ,Dose prescription ,Radiation therapy ,Carcinoma, Intraductal, Noninfiltrating ,Oncology ,Large breast ,Female ,Radiology ,business ,Quality assurance - Abstract
PURPOSE To describe the quality assurance (QA) program and early toxicities in the phase III randomized trial BONBIS (NCT00907868) on the role of a localized radiation boost in ductal carcinoma in situ (DCIS). MATERIALS AND METHODS From November 2008 to July 2014, 2004 patients were randomized in arm A (only whole breast radiotherapy, WBRT) and arm B (WBRT + boost). The QA program involved 44 participant centers that performed the dummy run (DR). Compliance and uniformity of clinical target volume (CTV) delineations, and dose prescription and delivery according to the BONBIS trial radiotherapy guidelines were analyzed. Acute toxicities (during and up to 3 months after radiotherapy completion, NCI-CTCAE v3.0 classification) were evaluated in 1929 patients. RESULTS The differences in whole breast CTV (CTV1) and planning target volume (PTV1) were ≤10%, and the differences in boost CTV (CTV2) and PTV (PTV2) were ≥20% compared with the reference DR values; 95% of the prescribed dose encompassed 98.7% and 100% of the median CTV1 and CTV2. Grade ≥2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p
- Published
- 2021
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