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Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010).

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机构: [1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [2]Clinical Trial Center, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [3]Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China [4]Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China [5]Department of Gynecologic Oncology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China [6]Department of Gynecologic Oncology, Women's Hospital of Zhejiang University, Hangzhou, China [7]Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China [8]Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China [9]Department of Gynecology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, China [10]Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China
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关键词: cervical cancer gynecologic surgical procedures pathology SLN and lympadenectomy

摘要:
There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone. To comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis. It is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given. All eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors. Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma. The primary endpoint is disease-free survival. Estimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively. As of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026. NCT02642471. © IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 3 区 妇产科学 4 区 肿瘤学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 妇产科学 3 区 肿瘤学
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出版当年[2018]版:
Q3 OBSTETRICS & GYNECOLOGY Q4 ONCOLOGY
最新[2023]版:
Q1 OBSTETRICS & GYNECOLOGY Q1 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者机构: [1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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通讯机构: [1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [*1]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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