A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial

doi:10.1186/s12885-022-09494-4

	A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial
	Wu, Xin 1; Feng, Hao 1; Gao, Shujun 1; Feng, Hua 1; Diao, Wenjing 1; Zhang, Hongwei 1; Du, Ming 1; Lou, Weihua 2; Wang, Xipeng 3; Zhu, Tao 4
刊名	BMC CANCER
	2022-04-09
卷号	22
关键词	Cervical cancer Stage IA1 with LVSI and IA2 Laparoscopic radical hysterectomy Abdominal radical hysterectomy Progression-free survival Overall survival Prognosis
DOI	10.1186/s12885-022-09494-4
通讯作者	Du, Yan(sophiedu_61@163.com) ; Jiang, Hua(jianghua@fudan.edu.cn)
英文摘要	Background: A retrospective study and a randomized controlled trial published in a high quality journal in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival than abdominal RH among patients with early stage cervical cancer. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology, therefore this conclusion is pivotal. The current trial is designed to reconfirm whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stage IA1 with LVSI, IA2) patient survival under stringent operation standards and consistent tumor-free technique. This paper reports the rationale, design, and implementation of the trial. Methods: This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 690 patients with stage IA1 (with intravascular), and IA2 cervical cancer will be enrolled over a period of three years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed-up for at least five years. The primary endpoint will be 5-year progression-free survival. Secondary endpoints will include 5-year overall survival rates, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and quality of life. Discussion: The results of the trial will provide valuable evidence for guiding clinical decision of choosing appropriate treatment strategies for stage IA1 (LVSI) and stage IA2 cervical cancer patients.
资助项目	Shanghai Shenkang Hospital Development Center's Shenkang Promotion of Clinical Skills and Clinical Innovation in Municipal Hospitals Three-Year Action Plan (2020-2023) Major Clinical Research Project[SHDC2020CR1048B]
WOS关键词	MANAGEMENT ; GUIDELINES ; OUTCOMES
WOS研究方向	Oncology
语种	英语
出版者	BMC
WOS记录号	WOS:000781372200008
资助机构	Shanghai Shenkang Hospital Development Center's Shenkang Promotion of Clinical Skills and Clinical Innovation in Municipal Hospitals Three-Year Action Plan (2020-2023) Major Clinical Research Project
内容类型	期刊论文
源URL	[http://ir.hfcas.ac.cn:8080/handle/334002/128525]
专题	中国科学院合肥物质科学研究院
通讯作者	Du, Yan; Jiang, Hua
作者单位	1.Fudan Univ, Obstet & Gynecol Hosp, Shanghai 200011, Peoples R China 2.Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai 200127, Peoples R China 3.Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Shanghai 200092, Peoples R China 4.Univ Chinese Acad Sci, Canc Hosp, Zhejiang Canc Hosp, Hangzhou 310005, Peoples R China 5.Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou 325000, Peoples R China 6.Fudan Univ, Zhongshan Hosp, Shanghai 200032, Peoples R China 7.Fudan Univ, Childrens Hosp, Shanghai 201102, Peoples R China
推荐引用方式 GB/T 7714	Wu, Xin,Feng, Hao,Gao, Shujun,et al. A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial[J]. BMC CANCER,2022,22.
APA	Wu, Xin.,Feng, Hao.,Gao, Shujun.,Feng, Hua.,Diao, Wenjing.,...&Jiang, Hua.(2022).A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial.BMC CANCER,22.
MLA	Wu, Xin,et al."A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial".BMC CANCER 22(2022).