MIRRORS-RCT Pilot: Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer
MIRRORS-RCTP
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
1 other identifier
interventional
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable ovarian-cancer
Started Oct 2023
Shorter than P25 for not_applicable ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 18, 2023
November 1, 2023
1.2 years
June 17, 2023
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment
Number of patients consented compared to the number offered inclusion expressed as a percentage.
Assessed at close of recruitment 6-8 months (recruitment period)
Secondary Outcomes (11)
Rate of conversion to open surgery
through study completion, an average of 1 year
Blood loss
through study completion, an average of 1 year
Maximal macroscopic cytoreduction rate (R=0 rate)
through study completion, an average of 1 year
Surgical complications
through study completion, an average of 1 year
Length of stay
through study completion, an average of 1 year
- +6 more secondary outcomes
Study Arms (2)
MIRRORS Protocol
EXPERIMENTALDiagnostic 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.
Standard Care
ACTIVE COMPARATORStandard Care - Open Interval Cytoreductive Surgery Surgery will proceed directly with standard open interval cytoreductive surgery through an extended midline incision
Interventions
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.
Extended midline incision. Open surgical approach to interval cytoreductive surgery with the aim of removing all visible disease.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Surrey NHS Foundation Trust
Guildford, Surrey, GU2 7XX, United Kingdom
Related Publications (1)
Uwins 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: 38561194RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Butler-Manuel, MD
Royal Surrey NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sub-Speciality Fellow in Gynaecological Oncology and Associate PI
Study Record Dates
First Submitted
June 17, 2023
First Posted
July 27, 2023
Study Start
October 2, 2023
Primary Completion
December 1, 2024
Study Completion
December 31, 2024
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- up to 5 years following completion and publication of the study
- Access Criteria
- The datasets generated from this current study will be available upon request from Miss Christina Uwins (Christina.Uwins@nhs.net) as raw anonymised data
The datasets generated from this current study will be available upon request from Miss Christina Uwins (Christina.Uwins@nhs.net) as raw anonymised data for up to 5 years following completion and publication of the study. Participants have given their consent for the information collected from this study to be used to support other research in the future and to be shared anonymously with other researchers.