J Gynecol Oncol.
2023 Mar;34(2):e13. 10.3802/jgo.2023.34.e13.
Intraoperative frozen pathology exam of Common iliac lymph nodes and Para-Aortic lymphadenectomy on the prognosis and quality of life for patients with IB2-IIA2 Cervical Cancer: trial protocol for a randomized controlled trial (C-PACC trial)
- Affiliations
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- 1Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
- 2Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, China
- 3Department of Gynecologic Oncology, Sichuan Cancer Hospital, Chengdu, China
- 4Department of Obstetrics and Gynecology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- 5Department of Gynecologic Oncology, The International Peace Maternity & Child Health Hospital (IPMCH) of China Welfare Institute (CWI), Shanghai, China
- 6Department of Obstetrics and Gynecology, The Sixth Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, China
- 7Department of Obstetrics and Gynecology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University of Medicine, Shanghai, China
- 8Department of Gynecology, First Maternity and Infant Hospital affiliated to Tongji University, Shanghai, China
- KMID: 2552522
- DOI: http://doi.org/10.3802/jgo.2023.34.e13
Abstract
- Background
The impact of para-aortic lymphadenectomy (PALD) on prognosis and quality of life (QoL) for IB2-IIA2 cervical cancer patients remain controversial. And whether intraoperative frozen pathology exam on common iliac lymph nodes could help predict para-aortic lymph node (PALN) metastasis was unanswered with high-level evidence.
Methods
A multi-center, randomized controlled study is intended to investigate the effect of PALD on the prognosis and QoL in cervical cancer patients and to assess the value of intraoperative frozen pathological evaluation of common iliac nodes metastasis for the prediction of PALN metastasis. After choosing whether to receive intraoperative frozen pathological examination of bilateral common iliac lymph nodes, eligible patients will be randomly assigned (1:1) to receive PALD or not. The primary end point is 2-year progression-free survival (PFS). The secondary end points include 5-year PFS, 2-year overall survival (OS), 5-year OS, adverse events (AEs) caused by PALD, AEs caused by radiotherapy and QoL. A total of 728 patients will be enrolled from 8 hospitals in China within 3-year period and followed up for 5 years.
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