A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial

Trials

Study Protocol

Tao Zhu¹  Weili Yan²  Shurong Zhu³  Zhiling Zhu³  Ling Qiu³  Hao Feng³  Wenjing Diao³  Ming Du³  Yan Du³  Hongwei Zhang³  Hua Jiang³  Xiaohong Xue³  Weiguo Hu³  Xin Wu³  Shujun Gao³  Hailin Yu³  Hua Feng³  Yanli Hou⁴  Weihua Lou⁴  Yongrui Bai⁴  Yuyang Zhang⁵  Jiarui Li⁶  Xuhong Fang⁶  Xipeng Wang⁶  Libing Xiang⁷ 

[1] Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China;Children’s Hospital of Fudan University, Shanghai, China;Obstetrics and Gynecology Hospital, Fudan University, 128 Shenyang Rd 200090, Shanghai, China;Shanghai Jiao Tong University School of Medicine, Renji Hospital, Shanghai, China;The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China;Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China;Zhongshan Hospital Affiliated to Fudan University, Shanghai, China;

关键词: Cervical cancer;    Stages IB3 and IIA2;    Laparoscopic radical hysterectomy;    Abdominal radical hysterectomy;    Randomized controlled trials;    Overall survival;    Progression-free survival;    Prognosis;   

DOI  :  10.1186/s13063-023-07573-w

 received in 2022-08-18, accepted in 2023-08-04,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundCervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial.Methods/designThis is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 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 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements.DiscussionThe study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.Trial registrationClinicalTrials.gov, NCT04939831, retrospectively registered on 25 June 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

13690_2023_1154_Article_IEq12.gif

Fig. 2

Fig. 1

Fig. 1