The MIRRORS study is a United Kingdom–based prospective study that intends to establish the feasibility of launching a randomized controlled trial of robotic interval debulking surgery for patients with ovarian cancer. The study, which opened in June 2020, will focus on the feasibility of obtaining consent from women and the acceptability of robotic interval debulking surgery for advanced ovarian cancer.
The MIRRORS study will enroll adult women with stage IIIC-IVB ovarian cancer, including cancer of the fallopian tube and peritoneum. Eligible participants will be patients who are undergoing neoadjuvant chemotherapy, with a pelvic mass of ≤8 cm, and who are considered suitable candidates for interval debulking surgery. Patients with a pelvic mass >8 cm will be excluded, as will those in whom an open surgical approach is deemed necessary. Researchers note that the inclusion criteria are intentionally wide, and do not restrict enrollment based on body mass index, patient comorbidity, or CA 125 levels.
An initial laparoscopic assessment will be performed on enrolled patients, followed by a decision to proceed to robotic or open interval debulking surgery. The goal of surgery is to remove all visible disease safely by either route. Conversion to open surgery will be done when required to attain this goal.
All women recruited to the MIRRORS study will be followed to assess recovery, complication rate, pain, and quality of life. If predefined success criteria are met, researchers will progress to MIRRORS-RCT, a randomized controlled trial of robotic interval debulking surgery for ovarian cancer. Success criteria will include an acceptance rate by eligible participants of ≥20% for inclusion into the study, a robotic interval debulking surgery complication rate that is not higher than for open surgery, and a conversion rate to open surgery of ≤50% for patients who were deemed suitable candidates for robotic surgery.
Researchers conclude that robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly in patients with a large pelvic mass or extensive disease in the upper abdomen. However, they hope to determine whether robotic surgery offers improved quality of life and recovery in selected women, with equivalent overall and progression-free survival.
Abstract 255. ESGO 2020.