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Efficacy of lymph node dissection on stage IIICr of cervical cancer before CCRT: study protocol for a phase III, randomized controlled clinical trial (CQGOG0103)

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单位: [1]Department of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China. [2]Gansu Provincial Maternity and Child-Care Hospital/Gansu Provincial Central Hospital, Lanzhou, China. [3]Fourth Hospital of Hebei Medical University, Hebei, China. [4]Department of Gynecologic Radiation Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China. [5]Institute of Cancer and Casic Medicine (IBMC), Chinese Academy of Science, Hangzhou, China. [6]Zhejiang Key Laboratory of Radiation Oncology, Hangzhou, China. [7]Department of Gynecological Oncology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China. [8]Department of Gynecologic Oncology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China. [9]Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China. [10]Department of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China. [11]Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, China. [12]Cancer Hospital of Shantou University Medicine College, Shantou, China
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关键词: Lymph Node Dissection Stage IIICr Cervical Cancer RCT

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Cervical cancer is still present a major public health problem, especially in developing countries. In International Federation of Gynaecology and Obstetrics 2018, allowing assessment of retroperitoneal lymph nodes by imaging and/or pathological findings and, if deemed metastatic, the case is designated as stage IIIC (with r and p notations). Patients with lymph node metastases have lower overall survival (OS), progression free survival (PFS), and survival after recurrence, especially those who have unresectable macroscopical positive lymph nodes. Retrospective analysis suggests that there may be a benefit to debulking macroscopic nodes that would be otherwise difficult to sterilize with standard doses of radiation therapy. However, there are no prospective study reporting that resecting macroscopic nodes before concurrent chemoradiation therapy (CCRT) would improve PFS or OS of cervical cancer and no guidelines for surgical resection of bulky lymph nodes. The CQGOG0103 study is a prospective, multicenter and randomized controlled trial (RCT) evaluating lymph node dissection on stage IIICr of cervical cancer.Eligible patients are histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma. Stage IIICr (confirmed by computed tomography [CT]/magnetic resonance imaging/positron emission tomography/CT) and the short diameter of image-positive lymph node ≥15 mm. 452 patients will be equally randomized to receive either CCRT (pelvic external-beam radiotherapy [EBRT]/extended-field EBRT + cisplatin [40 mg/m²] or carboplatin [the area under curve=2] every week for 5 cycles + brachytherapy) or open/minimally invasive pelvic and para-aortic lymph node dissection followed by CCRT. Randomization is stratified by status of para-aortic lymph node. The primary endpoint is PFS. Secondary endpoints are OS and surgical complications. A total of 452 patients will be enrolled from multiple hospitals in China within 4 years and followed up for 5 years.ClinicalTrials.gov Identifier: NCT04555226.© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.

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出版当年[2022]版:
大类 | 2 区 医学
小类 | 1 区 妇产科学 2 区 肿瘤学
最新[2025]版:
大类 | 2 区 医学
小类 | 3 区 妇产科学 3 区 肿瘤学
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出版当年[2021]版:
Q1 OBSTETRICS & GYNECOLOGY Q2 ONCOLOGY
最新[2023]版:
Q1 OBSTETRICS & GYNECOLOGY Q2 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

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第一作者单位: [1]Department of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China.
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通讯机构: [1]Department of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China. [*1]Department of Gynecology Oncology, Chongqing University Cancer Hospital, 181 Hanyu Road, Shapingba District, Chongqing 400030, China
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