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
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Authors
Wu, Xin
Feng, Hao
Gao, Shujun
Feng, Hua
Diao, Wenjing
Zhang, Hongwei
Du, Ming
Lou, Weihua
Wang, Xipeng
Zhu, Tao
Issue Date
2022-04-09
Type
Article
Language
en_US
Keywords
Cervical Cancer , Stage IA1 with LVSI and IA2 , Laparoscopic Radical Hysterectomy , Abdominal Radical Hysterectomy , Progression-Free Survival , Overall Survival , Prognosis
Alternative Title
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.
Description
Citation
Wu, X., Feng, H., Gao, S., Feng, H., Diao, W., Zhang, H., Du, M., Lou, W., Wang, X., Zhu, T., Zhang, Y., Hu, W., Xue, X., Zhu, Z., Xiang, L., Li, J., Fang, X., Bai, Y., Hou, Y., Yan, W., … Jiang, H. (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(1), 384. https://doi.org/10.1186/s12885-022-09494-4
Publisher
BMC Cancer