PMID- 36424705
OWN - NLM
STAT- MEDLINE
DCOM- 20230310
LR  - 20230323
IS  - 2005-0399 (Electronic)
IS  - 2005-0380 (Print)
IS  - 2005-0380 (Linking)
VI  - 34
IP  - 2
DP  - 2023 Mar
TI  - 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).
PG  - e13
LID - 10.3802/jgo.2023.34.e13 [doi]
LID - e13
AB  - 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. TRIAL 
      REGISTRATION: Chinese Clinical Trial Register Identifier: ChiCTR2000035668.
CI  - (c) 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic 
      Oncology, and Japan Society of Gynecologic Oncology.
FAU - Qu, Xinyu
AU  - Qu X
AUID- ORCID: 0000-0001-6655-6085
AD  - Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 
      Shanghai, China.
FAU - Qiu, Junjun
AU  - Qiu J
AUID- ORCID: 0000-0002-2063-2684
AD  - Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 
      Shanghai, China.
FAU - Jiang, Lili
AU  - Jiang L
AUID- ORCID: 0000-0002-4346-2171
AD  - Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 
      Shanghai, China.
FAU - Qi, Xiaorong
AU  - Qi X
AUID- ORCID: 0000-0002-8382-9433
AD  - Department of Obstetrics and Gynecology, West China Second University Hospital of 
      Sichuan University, Chengdu, China.
FAU - Zhang, Guonan
AU  - Zhang G
AUID- ORCID: 0000-0002-2228-9197
AD  - Department of Gynecologic Oncology, Sichuan Cancer Hospital, Chengdu, China.
FAU - Feng, Weiwei
AU  - Feng W
AUID- ORCID: 0000-0002-0685-9479
AD  - Department of Obstetrics and Gynecology, Ruijin Hospital Affiliated to Shanghai 
      Jiaotong University School of Medicine, Shanghai, China.
FAU - Wang, Yudong
AU  - Wang Y
AUID- ORCID: 0000-0002-9455-4471
AD  - Department of Gynecologic Oncology, The International Peace Maternity & Child 
      Health Hospital (IPMCH) of China Welfare Institute (CWI), Shanghai, China.
FAU - Teng, Yincheng
AU  - Teng Y
AUID- ORCID: 0000-0003-0772-3335
AD  - Department of Obstetrics and Gynecology, The Sixth Hospital of Shanghai Jiaotong 
      University School of Medicine, Shanghai, China.
FAU - Wang, Xipeng
AU  - Wang X
AUID- ORCID: 0000-0001-8393-3719
AD  - Department of Obstetrics and Gynecology, Xinhua Hospital Affiliated to Shanghai 
      Jiao Tong University of Medicine, Shanghai, China.
FAU - Guo, Xiaoqing
AU  - Guo X
AUID- ORCID: 0000-0002-2493-5156
AD  - Department of Gynecology, First Maternity and Infant Hospital affiliated to 
      Tongji University, Shanghai, China.
FAU - Hua, Keqin
AU  - Hua K
AUID- ORCID: 0000-0001-5359-8841
AD  - Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 
      Shanghai, China. huakeqin@fudan.edu.cn.
LA  - eng
GR  - SHDC2020CR1045B/Clinical Research Plan of SHDC/
GR  - SHDC2020CR6009/Clinical Research Plan of SHDC/
GR  - SHDC2020CR4087/Clinical Research Plan of SHDC/
GR  - 22Y31900500/Shanghai Committee of Science and Technology/
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221114
PL  - Korea (South)
TA  - J Gynecol Oncol
JT  - Journal of gynecologic oncology
JID - 101483150
SB  - IM
MH  - Female
MH  - Humans
MH  - *Uterine Cervical Neoplasms/pathology
MH  - Quality of Life
MH  - Neoplasm Staging
MH  - Lymph Node Excision/methods
MH  - Lymph Nodes/surgery/pathology
MH  - Prognosis
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
PMC - PMC9995868
OTO - NOTNLM
OT  - Lymphadenectomy
OT  - Radiotherapy
OT  - Uterine Cervical Neoplasms
COIS- No potential conflict of interest relevant to this article was reported.
EDAT- 2022/11/26 06:00
MHDA- 2023/03/11 06:00
PMCR- 2023/03/01
CRDT- 2022/11/25 00:13
PHST- 2022/09/13 00:00 [received]
PHST- 2022/10/18 00:00 [revised]
PHST- 2022/11/07 00:00 [accepted]
PHST- 2022/11/26 06:00 [pubmed]
PHST- 2023/03/11 06:00 [medline]
PHST- 2022/11/25 00:13 [entrez]
PHST- 2023/03/01 00:00 [pmc-release]
AID - 34.e13 [pii]
AID - 10.3802/jgo.2023.34.e13 [doi]
PST - ppublish
SO  - J Gynecol Oncol. 2023 Mar;34(2):e13. doi: 10.3802/jgo.2023.34.e13. Epub 2022 Nov 
      14.