POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial

Abstract Background Various randomized trials have demonstrated that postmastectomy radiotherapy (RT) to the chest wall and comprehensive regional nodal areas improves survival in patients with axillary node-positive breast cancer. Controversy exists as to whether the internal mammary node (IMN) reg...

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Autores principales:	Xu-Ran Zhao, Hui Fang, Yu Tang, Zhi-Hui Hu, Hao Jing, Lin Liang, Xue-Na Yan, Yong-Wen Song, Jing Jin, Yue-Ping Liu, Bo Chen, Yuan Tang, Shu-Nan Qi, Ning Li, Ning-Ning Lu, Kuo Men, Chen Hu, Yu-Hui Zhang, Ye-Xiong Li, Shu-Lian Wang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Breast cancer Postmastectomy radiotherapy Internal mammary node irradiation Survival outcome Toxicity Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/720646122bba4436825e23c09a3468a0
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spelling	oai:doaj.org-article:720646122bba4436825e23c09a3468a02021-11-08T11:02:22ZPOstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial10.1186/s12885-021-08852-y1471-2407https://doaj.org/article/720646122bba4436825e23c09a3468a02021-11-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08852-yhttps://doaj.org/toc/1471-2407Abstract Background Various randomized trials have demonstrated that postmastectomy radiotherapy (RT) to the chest wall and comprehensive regional nodal areas improves survival in patients with axillary node-positive breast cancer. Controversy exists as to whether the internal mammary node (IMN) region is an essential component of regional nodal irradiation. Available data on the survival benefit of IMN irradiation (IMNI) are conflicting. The patient populations enrolled in previous studies were heterogeneous and most studies were conducted before modern systemic treatment and three-dimensional (3D) radiotherapy (RT) techniques were introduced. This study aims to assess the efficacy and safety of IMNI in the context of modern systemic treatment and computed tomography (CT)-based RT planning techniques. Methods POTENTIAL is a prospective, multicenter, open-label, parallel, phase III, randomized controlled trial investigating whether IMNI improves disease-free survival (DFS) in high-risk breast cancer with positive axillary nodes (pN+) after mastectomy. A total of 1800 patients will be randomly assigned in a 1:1 ratio to receive IMNI or not. All patients are required to receive ≥ six cycles of anthracycline and/or taxane-based chemotherapy. Randomization will be stratified by institution, tumor location (medial/central vs. other quadrants), the number of positive axillary nodes (1–3 vs. 4–9 vs. ≥10), and neoadjuvant chemotherapy (yes vs. no). Treatment will be delivered with CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy. The prescribed dose is 50 Gy in 25 fractions or 43.5 Gy in 15 fractions. Tiered RT quality assurance is required. After RT, patients will be followed up at regular intervals. Oncological and toxilogical outcomes, especially cardiac toxicities, will be assessed. Discussion This trial design is intended to overcome the limitations of previous prospective studies by recruiting patients with pN+ breast cancer, using DFS as the primary endpoint, and prospectively assessing cardiac toxicities and requiring RT quality assurance. The results of this study will provide high-level evidence for elective IMNI in patients with breast cancer after mastectomy. Trial registration ClinicalTrails.gov , NCT04320979 . Registered 25 Match 2020, https://clinicaltrials.gov/ct2/show/NCT04320979Xu-Ran ZhaoHui FangYu TangZhi-Hui HuHao JingLin LiangXue-Na YanYong-Wen SongJing JinYue-Ping LiuBo ChenYuan TangShu-Nan QiNing LiNing-Ning LuKuo MenChen HuYu-Hui ZhangYe-Xiong LiShu-Lian WangBMCarticleBreast cancerPostmastectomy radiotherapyInternal mammary node irradiationSurvival outcomeToxicityNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Breast cancer Postmastectomy radiotherapy Internal mammary node irradiation Survival outcome Toxicity Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Breast cancer Postmastectomy radiotherapy Internal mammary node irradiation Survival outcome Toxicity Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Xu-Ran Zhao Hui Fang Yu Tang Zhi-Hui Hu Hao Jing Lin Liang Xue-Na Yan Yong-Wen Song Jing Jin Yue-Ping Liu Bo Chen Yuan Tang Shu-Nan Qi Ning Li Ning-Ning Lu Kuo Men Chen Hu Yu-Hui Zhang Ye-Xiong Li Shu-Lian Wang POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial
description	Abstract Background Various randomized trials have demonstrated that postmastectomy radiotherapy (RT) to the chest wall and comprehensive regional nodal areas improves survival in patients with axillary node-positive breast cancer. Controversy exists as to whether the internal mammary node (IMN) region is an essential component of regional nodal irradiation. Available data on the survival benefit of IMN irradiation (IMNI) are conflicting. The patient populations enrolled in previous studies were heterogeneous and most studies were conducted before modern systemic treatment and three-dimensional (3D) radiotherapy (RT) techniques were introduced. This study aims to assess the efficacy and safety of IMNI in the context of modern systemic treatment and computed tomography (CT)-based RT planning techniques. Methods POTENTIAL is a prospective, multicenter, open-label, parallel, phase III, randomized controlled trial investigating whether IMNI improves disease-free survival (DFS) in high-risk breast cancer with positive axillary nodes (pN+) after mastectomy. A total of 1800 patients will be randomly assigned in a 1:1 ratio to receive IMNI or not. All patients are required to receive ≥ six cycles of anthracycline and/or taxane-based chemotherapy. Randomization will be stratified by institution, tumor location (medial/central vs. other quadrants), the number of positive axillary nodes (1–3 vs. 4–9 vs. ≥10), and neoadjuvant chemotherapy (yes vs. no). Treatment will be delivered with CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy. The prescribed dose is 50 Gy in 25 fractions or 43.5 Gy in 15 fractions. Tiered RT quality assurance is required. After RT, patients will be followed up at regular intervals. Oncological and toxilogical outcomes, especially cardiac toxicities, will be assessed. Discussion This trial design is intended to overcome the limitations of previous prospective studies by recruiting patients with pN+ breast cancer, using DFS as the primary endpoint, and prospectively assessing cardiac toxicities and requiring RT quality assurance. The results of this study will provide high-level evidence for elective IMNI in patients with breast cancer after mastectomy. Trial registration ClinicalTrails.gov , NCT04320979 . Registered 25 Match 2020, https://clinicaltrials.gov/ct2/show/NCT04320979
format	article
author	Xu-Ran Zhao Hui Fang Yu Tang Zhi-Hui Hu Hao Jing Lin Liang Xue-Na Yan Yong-Wen Song Jing Jin Yue-Ping Liu Bo Chen Yuan Tang Shu-Nan Qi Ning Li Ning-Ning Lu Kuo Men Chen Hu Yu-Hui Zhang Ye-Xiong Li Shu-Lian Wang
author_facet	Xu-Ran Zhao Hui Fang Yu Tang Zhi-Hui Hu Hao Jing Lin Liang Xue-Na Yan Yong-Wen Song Jing Jin Yue-Ping Liu Bo Chen Yuan Tang Shu-Nan Qi Ning Li Ning-Ning Lu Kuo Men Chen Hu Yu-Hui Zhang Ye-Xiong Li Shu-Lian Wang
author_sort	Xu-Ran Zhao
title	POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial
title_short	POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial
title_full	POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial
title_fullStr	POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial
title_full_unstemmed	POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial
title_sort	postmastectomy radiotherapy in node-positive breast cancer with or without internal mammary nodal irradiation (potential): a study protocol for a multicenter prospective phase iii randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/720646122bba4436825e23c09a3468a0
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POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial

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