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BRIDGE −1 TRIAL: BReak Interval Delayed surgery for Gastrointestinal Extraperitoneal rectal cancer, a multicentric phase III randomized trial

التفاصيل البيبلوغرافية
العنوان: BRIDGE −1 TRIAL: BReak Interval Delayed surgery for Gastrointestinal Extraperitoneal rectal cancer, a multicentric phase III randomized trial
المؤلفون: Giuditta Chiloiro, Elisa Meldolesi, Barbara Corvari, Angela Romano, Brunella Barbaro, Claudio Coco, Antonio Crucitti, Domenico Genovesi, Marco Lupattelli, Giovanna Mantello, Roberta Menghi, Mattia Falchetto Osti, Roberto Persiani, Lucio Petruzziello, Riccardo Ricci, Luigi Sofo, Chiara Valentini, Antonino De Paoli, Vincenzo Valentini, Maria Antonietta Gambacorta
المصدر: Clinical and Translational Radiation Oncology, Vol 34, Iss , Pp 30-36 (2022)
بيانات النشر: Elsevier, 2022.
سنة النشر: 2022
المجموعة: LCC:Medical physics. Medical radiology. Nuclear medicine
LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
مصطلحات موضوعية: Rectal cancer, Surgical Interval, Neoadjuvant chemoradiotherapy, Personalized treatment, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
الوصف: Design: Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC).Several studies have shown a correlation between a longer interval between the end of nCRT and surgery (surgical interval - SI) and an increased pathological complete response (pCR) rate, with a maximum obtained between 10 and 13 weeks.The primary endpoint of this multicenter, 2-arm randomised trial is to investigate SI lengthening, evaluating the difference in terms of complete response (CR) and Tumor Regression Grade (TRG)1 rate in the two arms. Secondly, the impact of SI lengthening on survival outcomes and quality of life (QoL) will be investigated. Methods: Intermediate-risk LARC patients undergoing nCRT will be prospectively included in the study. nCRT will be administered with a total dose of 55 Gy in 25 fractions on Gross Tumor Volume (GTV) plus the corresponding mesorectum of 45 Gy in 25 fractions on the whole pelvis. Chemotherapy with oral capecitabine will be administered continuously.The patients achieving a clinical major or complete response assessed at clinical-instrumental re-evaluation at 7–8 weeks after treatment completion, will be randomized into two groups, to undergo surgery or local excision at 9–11 weeks (control arm) or at 13–16 weeks (experimental arm). Pathological response will be assessed on the surgical specimen using the AJCC TNM v.7 and the TRG according to Mandard. Patients will be followed up to evaluate toxicity and QoL.The promoter center of the trial will conduct the randomization process through an automated procedure to prevent any possible bias.For sample size calculation, using CR difference of 20% as endpoint, 74 patients per arm will be enrolled. Conclusions: The results of this study may prospectively provide a new time frame for the clinical re-evaluation for complete/major responders patients in order to increase the CR rate to nCRT.Trial registration:ClinicalTrials.gov Identifier: NCT03581344.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 2405-6308
Relation: http://www.sciencedirect.com/science/article/pii/S2405630822000155; https://doaj.org/toc/2405-6308
DOI: 10.1016/j.ctro.2022.03.002
URL الوصول: https://doaj.org/article/7ca63f4d1f184465bdd66e69fc8cbc38
رقم الأكسشن: edsdoj.7ca63f4d1f184465bdd66e69fc8cbc38
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:24056308
DOI:10.1016/j.ctro.2022.03.002