Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol
Soo Jin Park,
Tae Wook Kong,
Taehun Kim,
Maria Lee,
Chel Hun Choi,
Seung-Hyuk Shim,
Ga Won Yim,
Seungmee Lee,
Eun Ji Lee,
Myong Cheol Lim,
Suk-Joon Chang,
Sung Jong Lee,
San Hui Lee,
Taejong Song,
Yoo-Young Lee,
Hee Seung Kim,
Eun Ji Nam
Affiliations
Soo Jin Park
Department of Obstetrics and Gynecology, Seoul National University College of Medicine
Tae Wook Kong
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Taehun Kim
Department of Obstetrics and Gynecology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Maria Lee
Department of Obstetrics and Gynecology, Seoul National University College of Medicine
Chel Hun Choi
Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seung-Hyuk Shim
Department of Obstetrics and Gynecology, Research Institute of Medical Science, Konkuk University School of Medicine
Ga Won Yim
Department of Obstetrics and Gynecology, Dongguk University College of Medicine
Seungmee Lee
Department of Obstetrics and Gynecology, Keimyung University School of Medicine
Eun Ji Lee
Department of Obstetrics and Gynecology, Seoul National University College of Medicine
Myong Cheol Lim
Division of Tumor Immunology, Research Institute, and Center for Gynecologic Cancer & Center for Clinical Trial, Hospital, and Department of Cancer Control & Population Health, GSCSP, National Cancer Center
Suk-Joon Chang
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Sung Jong Lee
Department of Obstetrics and Gynecology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
San Hui Lee
Department of Obstetrics and Gynecology, Wonju Severance Christian Hospital, Yonsei University College of Medicine
Taejong Song
Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Yoo-Young Lee
Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Hee Seung Kim
Department of Obstetrics and Gynecology, Seoul National University College of Medicine
Eun Ji Nam
Hereditary Cancer Clinic, Cancer Prevention Center, Yonsei Cancer Center, and Department of Obstetrics and Gynecology, Institute of Women’s Life Medical Science, Women’s Cancer Clinic, Yonsei University College of Medicine
Abstract Background The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer. Methods This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%. Discussion We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery. Trial registration ClinicalTrials.gov ; NCT04370496 ; registration date, May 2020.
