NDLI: 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

Content Provider	Springer Nature : BioMed Central
Author	Wu, Xin Feng, Hao Gao, Shujun Feng, Hua Diao, Wenjing Zhang, Hongwei Du, Ming Lou, Weihua Wang, Xipeng Zhu, Tao Zhang, Yuyang Hu, Weiguo Xue, Xiaohong Zhu, Zhiling Xiang, Libing Li, Jiarui Fang, Xuhong Bai, Yongrui Hou, Yanli Yan, Weili Qiu, Ling Yu, Hailin Zhu, Shurong Du, Yan Jiang, Hua
Abstract	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. Trial registration ClinicalTrials.gov ( NCT04934982 , Registered on 22 June 2021).
Related Links	https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-022-09494-4.pdf
Ending Page	10
Page Count	10
Starting Page	1
File Format	HTM / HTML
ISSN	14712407
DOI	10.1186/s12885-022-09494-4
Journal	BMC Cancer
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2022-04-09
Access Restriction	Open
Subject Keyword	Cancer Research Oncology Surgical Oncology Health Promotion and Disease Prevention Biomedicine Medicine Public Health Cervical cancer Stage IA1 with LVSI and IA2 Laparoscopic radical hysterectomy Abdominal radical hysterectomy Progression-free survival Overall survival Prognosis Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Cancer Research Oncology Genetics
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	3.8/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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