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Abstract
Introduction/Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer (<4 cm tumour size; ESCC). Results from a randomized trial (’LACC’) demonstrated that minimally invasive surgery (MIS) is inferior to laparotomy with regards to disease-free and overall survival. Retrospective studies suggest that tumour spillage might be the cause for poorer outcomes after MIS. Another randomized phase III trial (’SHAPE’) comparing radical versus simple hysterectomy (SH) in low-risk ESCC showed non-inferiority of SH with better quality of life and sexual health measures. However, the question whether MIS is comparable to laparotomy regarding survival was not addressed. This highlights the need to evaluate preventive surgical methods in the MIS radical hysterectomy arm to assure tumour hygiene and to address MIS vs laparotomy for simple hysterectomy in low-risk ESCC.
Methodology Patients will be randomized to either undergo conventional standard radical hysterectomy including lymphadenectomy by laparotomy or MI radical hysterectomy (either by conventional laparoscopy or robotic-assisted) using preventive surgical methods in form of either performing a LEEP/cone prior to surgery or closure of the vagina before colpotomy and avoiding intrauterine manipulators. According to the SHAPE trial, a simple hysterectomy can be considered in patients with low-risk ESCC (tumour-size < 2cm and < 10 mm depth of stromal invasion after LEEP/cone).
Results The primary endpoint is disease-free survival (DFS). Non-inferiority of MIS compared to laparotomy will be declared if the upper boundary of the two-sided 95% confidence interval (CI) for the hazard ratio (MIS/laparotomy) is below the predefined non-inferiority margin of 2.3. Secondary endpoints include overall survival, disease recurrence, quality of life, complications and treatment-associated morbidity, treatment costs and cost effectiveness.
Conclusion This RCT aims to answer the question whether MIS is oncologically safe in ESCC with the advantage of fewer peri-operative complications and superior patient-reported outcomes.
Disclosures DD reports the receipt of honoraria/consultation fees from: AstraZeneca, Eisai, GSK, Intuitive, KLS Martin, MSD, PharmaMar, Seagen. The remaining authors certify that they have NO affiliations with or involvement in any organization or entity with any financial interest, or non-financial interest in the subject matter or materials discussed in this abstract.
