Clinical trial · Interventional
MIRRORS-RCT Pilot: Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer
MIRRORS-RCT (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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Neoplasm | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasm Epithelial | — | UNRESOLVED | — |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MIRRORS Protocol | Procedure | — | UNRESOLVED |
| Standard Open Cytoreductive Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MIRRORS Protocol
- description
- Diagnostic Laparoscopy proceed to either robotic or open Interval cytoreductive surgery with conversion to open at any point should this be required to remove all visible disease.
- interventionNames
- Procedure: MIRRORS Protocol
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Standard Care - Open Interval Cytoreductive Surgery Surgery will proceed directly with standard open interval cytoreductive surgery through an extended midline incision
- interventionNames
- Procedure: Standard Open Cytoreductive Surgery
Primary outcomes (1)
- measure
- Recruitment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with Stage IIIc-IVb epithelial ovarian cancer (EOC) (including cancer of the fallopian tube \& peritoneum) undergoing neo-adjuvant chemotherapy * Pelvic mass ≤8 cm on CT * Age ≥18years Exclusion Criteria: * A Pelvic Mass \>8cm * Not Suitable for interval cytoreductive surgery. * Lacks capacity to understand or complete trial documentation. * Patients not suitable for laparoscopy, * Specialist surgical support is required and open surgery is recommended by the speciality team involved.
References
Publications (1)
- RESULTUwins C, Assalaarachchi H, Bennett K, Read J, Tailor A, Crawshaw J, Chatterjee J, Ellis P, Skene SS, Michael A, Butler-Manuel S. MIRRORS: a prospective cohort study assessing the feasibility of robotic interval debulking surgery for advanced-stage ovarian cancer. Int J Gynecol Cancer. 2024 Jun 3;34(6):886-897. doi: 10.1136/ijgc-2024-005265. PMID 38561194