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

NCT05960630UNKNOWNNAINTERVENTIONAL

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

Key Facts

Lead Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Enrollment

Start Date

2023-10-02

Completion Date

2024-12-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

MIRRORS ProtocolStandard Open Cytoreductive Surgery

Conditions

Ovarian CancerOvarian NeoplasmOvarian Neoplasm EpithelialFallopian Tube CancerFallopian Tube NeoplasmsPeritoneal Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Recruitment

Number of patients consented compared to the number offered inclusion expressed as a percentage.

Time frame: Assessed at close of recruitment 6-8 months (recruitment period)

Secondary Outcomes

Rate of conversion to open surgery

Percentage of patients converted to open surgery after being deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy. Success criteria: Conversion to open surgery rate is less than 50% of the patient group deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.