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MIRRORS-RCT Pilot: Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer

NCT05960630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-18

No results posted yet for this study

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 recommencement 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, the investigators 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

Conditions

Interventions

PROCEDURE

MIRRORS Protocol

Diagnostic laparoscopic assessment proceeding to either robotic (if considered appropriate following laparoscopic assessment) or open Interval cytoreductive surgery with conversion to open at any point should this be required to remove all visible disease.

PROCEDURE

Standard Open Cytoreductive Surgery

Extended midline incision. Open surgical approach to interval cytoreductive surgery with the aim of removing all visible disease.

Sponsors & Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Simon Butler-Manuel, MD · Royal Surrey NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960630 on ClinicalTrials.gov