MIRRORS-RCT (Pilot)
Research type
Research Study
Full title
Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival (MIRRORS) – Pilot randomised controlled trial (RCT) of robotic interval cytoreductive surgery for advanced ovarian, fallopian tube and peritoneal cancer (EOC) following MIRRORS-protocol vs standard open interval cytoreductive surgery.
IRAS ID
279899
Contact name
Simon Butler-Manuel
Contact email
Sponsor organisation
Royal Surrey NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The survival of ovarian cancer patients is dependent on the stage at diagnosis; more than 70% of patients present with advanced stage disease (stage III/IV). In England, one-year survival is 98.7% at stage I and 51.4% at stage IV and five-year survival is 93.3% and 13.4% respectively. Standard treatment for advanced ovarian cancer involves surgery to remove all visible tumour and chemotherapy. Removal of all visible disease, so no tumour deposits are visible to the naked eye at the end of first‐line surgery, is one of the strongest predictors of overall survival.
A majority of the women presenting with advanced disease are older and frail. Extensive open surgery discriminates against such women as they may not be well enough for the surgery offered. A recent national audit in England found that 60.1% of women over the age of 79yrs diagnosed with ovarian cancer received no cancer treatment at all. The ability to provide the same surgery via a minimally invasive route such as robotic surgery potentially widens access to cancer treatment.
The MIRRORS Feasibility study (NCT04402333) completed recently at the Royal Surrey County Hospital in Guildford showed significantly enhanced recovery with short length of stay and reduced blood loss enabling faster re-commencement of chemotherapy in women with advanced disease undergoing robotic surgery compared to open surgery (requiring a cut in the abdomen).
In the current proposed study funded by Intuitive Foundation and GRACE Charity, we will establish the feasibility of conducting a randomised controlled trial and collect data from three hospital sites to inform a future phase 3 randomised controlled trial. The aim will be to to improve patient experience, access to surgery, recovery, reduce morbidity and reduce time to chemotherapy by incorporating robotic cytoreductive surgery into the ovarian cancer treatment pathway for women with a pelvic mass </=8cm.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0119
Date of REC Opinion
30 May 2023
REC opinion
Favourable Opinion