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Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy
DC Field | Value | Language |
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dc.contributor.author | Lee, Tae Hoon | - |
dc.contributor.author | Chang, Ji Hyun | - |
dc.contributor.author | Jang, Bum-Sup | - |
dc.contributor.author | Kim, Jae Sik | - |
dc.contributor.author | Kim, Tae Hyun | - |
dc.contributor.author | Park, Won | - |
dc.contributor.author | Kim, Yong Bae | - |
dc.contributor.author | Kim, Su Ssan | - |
dc.contributor.author | Han, Wonshik | - |
dc.contributor.author | Lee, Han-Byoel | - |
dc.contributor.author | Shin, Kyung Hwan | - |
dc.date.accessioned | 2022-12-26T06:12:46Z | - |
dc.date.available | 2022-12-26T15:14:13Z | - |
dc.date.issued | 2022-11-16 | - |
dc.identifier.citation | BMC Cancer. 2022 Nov 16;22(1):1179 | ko_KR |
dc.identifier.issn | 1471-2407 | - |
dc.identifier.uri | https://doi.org/10.1186/s12885-022-10285-0 | - |
dc.identifier.uri | https://hdl.handle.net/10371/187345 | - |
dc.description.abstract | Background
Postoperative radiotherapy (PORT) could be useful for pN1 breast cancer patients who have undergone breast-conserving surgery (BCS) or mastectomy. However, the value of regional nodal irradiation (RNI) for BCS patients, and the indications for post-mastectomy radiotherapy (PMRT) for pN1 breast cancer mastectomy patients, have recently been challenged due to the absence of relevant trials in the era of modern systemic therapy. PORT de-escalation should be assessed in patients with pN1 breast cancer. Methods The PORT-N1 trial is a multicenter, randomized, phase 3 clinical trial for patients with pN1 breast cancer that compares the outcomes of control [whole-breast irradiation (WBI) and RNI/PMRT] and experimental (WBI alone/no PMRT) groups. PORT-N1 aims to demonstrate non-inferiority of the experimental group by comparing 7-year disease-free survival rates with the control group. Female breast cancer patients with pT1-3 N1 status after BCS or mastectomy are eligible. Participants will be randomly assigned to the two groups in a 1:1 ratio. Randomization will be stratified by surgery type (BCS vs. mastectomy) and histologic subtype (triple-negative vs. non-triple-negative). In patients who receive mastectomy, dissection of ≥5 nodes is required when there is one positive node, and axillary lymph node dissection when there are two or three positive nodes. Patients receiving neoadjuvant chemotherapy are not eligible. RNI includes a high-tangent or wider irradiation field. This study will aim to recruit 1106 patients. Discussion The PORT-N1 trial aims to verify that PORT de-escalation after BCS or mastectomy is safe for pN1 breast cancer patients in terms of oncologic outcomes and capable of reducing toxicity rates. This trial will provide information crucial for designing PORT de-escalation strategies for patients with pN1 breast cancer. Trial registration This trial was registered at ClinicalTrials.gov (NCT05440149) on June 30, 2022. | ko_KR |
dc.description.sponsorship | This work was supported by the National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea (HA22C0044). The funding source was not involved in design of the study and collection, analysis, and interpretation of data and writing the manuscript. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BMC | ko_KR |
dc.subject | Adjuvant radiotherapy | - |
dc.subject | Breast cancer | - |
dc.subject | Lumpectomy | - |
dc.subject | Mastectomy | - |
dc.subject | pN1 | - |
dc.title | Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 이태훈 | - |
dc.contributor.AlternativeAuthor | 장지현 | - |
dc.contributor.AlternativeAuthor | 장범섭 | - |
dc.contributor.AlternativeAuthor | 김재식 | - |
dc.contributor.AlternativeAuthor | 김태현 | - |
dc.contributor.AlternativeAuthor | 박원 | - |
dc.contributor.AlternativeAuthor | 김용배 | - |
dc.contributor.AlternativeAuthor | 김수산 | - |
dc.contributor.AlternativeAuthor | 한원식 | - |
dc.contributor.AlternativeAuthor | 이한별 | - |
dc.contributor.AlternativeAuthor | 신경환 | - |
dc.identifier.doi | 10.1186/s12885-022-10285-0 | ko_KR |
dc.citation.journaltitle | BMC Cancer | ko_KR |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s) | - |
dc.date.updated | 2022-11-20T04:17:00Z | - |
dc.citation.number | 1 | ko_KR |
dc.citation.startpage | 1179 | ko_KR |
dc.citation.volume | 22 | ko_KR |
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