Robotic surgery for advanced ovarian cancer treatment
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
This study is testing if robotic surgery can safely remove tumors in women with advanced ovarian cancer after chemotherapy, and if it works better than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Royal Surrey County Hospital NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guildford, Surrey) |
| Trial ID | NCT05960630 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the feasibility of using robotic interval cytoreductive surgery in women with advanced epithelial ovarian cancer after neoadjuvant chemotherapy. The study aims to determine if this minimally invasive approach can safely facilitate maximal tumor removal and improve patient outcomes compared to standard open surgery. Eligible participants will be women with Stage IIIc-IVb ovarian cancer and a pelvic mass of 8 cm or less, who will be recruited and randomized to assess the protocol's effectiveness before a larger multicenter trial. The trial will also evaluate patient willingness to participate and the operational success of the MIRRORS protocol at multiple sites.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with Stage IIIc-IVb epithelial ovarian cancer and a pelvic mass of 8 cm or less who are undergoing neoadjuvant chemotherapy.
Not a fit: Patients with pelvic masses larger than 8 cm or those not suitable for interval cytoreductive surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer surgical option for older and frail women with advanced ovarian cancer, potentially improving their survival rates.
How similar studies have performed: While robotic surgery is gaining traction in various surgical fields, this specific approach for advanced ovarian cancer is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guildford, Surrey
- Royal Surrey NHS Foundation Trust — Guildford, Surrey, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Simon Butler-Manuel, MD — Royal Surrey NHS Foundation Trust
- Study coordinator: Christina M Uwins, MRCS MRCOG
- Email: christina.uwins@nhs.net
- Phone: 01483571122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.