Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival

Study Overview
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Brief Summary
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MIRRORS Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival is a new United Kingdom based prospective feasibility study the purpose of which is to establish the feasibility of launching a British multicentre randomised control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of the fallopian tube & peritoneum) in the future. This initial feasibility study will focus on the ability to recruit patients, acceptability, quality of life, the rate at which it is possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately the investigators would like to determine whether, in selected patients, robotic surgery offers improved quality of life and recovery with equivalent overall and progression free survival. Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those with large pelvic masses or extensive disease around the upper part of the abdomen, however, it has the potential to provide significant recovery and quality of life benefits to a selected group of patients. MIRRORS - ICG Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in patients with advanced ovarian cancers is a ancillary study within MIRRORS. Using ICG dye, the investigators aim to observe whether there are any changes in the blood vessel pattern associated with the tumour deposits the investigators remove that makes them distinctive. The ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in this ancillary research is not required for participation in the trial.

Detailed Description
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Hypothesis: in selected cases of ovarian cancer, following neoadjuvant chemotherapy, minimally invasive robotic surgery provides maximal debulking surgery and improved patient outcomes. Null Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery and patient outcomes are not improved. To assess the feasibility of obtaining consent from women and acceptability of Robotic interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval debulking surgery will be identified through the Gynaecological Oncology multidisciplinary team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20 women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian cancer. The main outcomes are feasibility of the recruitment process and acceptability of the questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and patient interviews. In order to be able to offer MIRRORS to as many patients as possible the investigators have kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient comorbidities or Ca125 level.

Official Title
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MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival

Conditions
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Ovarian Cancer, Ovarian Neoplasm, Ovarian Neoplasm Epithelial, Fallopian Tube Cancer, Peritoneal Cancer

Intervention / Treatment
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* Procedure: Robotic Interval Debulking Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women ≥18 years with Stage IIIc -IVb Ovarian cancer (including fallopian tube and peritoneal cancer) undergoing Neo-adjuvant Chemotherapy. Considered suitable for Interval debulking surgery ≤8cm pelvic mass MIRRORS ICG Inclusion Criteria - Same as above Exclusion Criteria: Pelvic mass >8cm, open surgical approach considered necessary following MDT review. Lacking capacity to the extent they are unable to understand or complete trial documentation / questionnaires. MIRRORS ICG Exclusion criteria will be: Severe renal insufficiency estimated Glomerular filtration rate (GFR)< 55ml/min, known allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic interval debulking surgery<br>Surgery will commence with an initial assessment with a camera inserted though the belly button. This visual assessment will be used to determine whether it is feasible to proceed with surgery robotically or whether full debulking surgery to zero macroscopic residual disease would be best carried out through an open surgical approach. If an open surgical approach is considered the optimum treatment for the patient and they have consented for this, then this will be done. If there is disease that cannot be removed Robotically after starting by this route, but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so. If there are any complications, we may also need to convert to open surgery. The aim of the surgery whether by robotic or open is to remove all visible disease safely. | Procedure: Robotic Interval Debulking Surgery<br>* Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.<br>|
| Open interval debulking surgery<br>Standard Care. Following initial laparoscopic assessment patients not deemed suitable for minimally invasive robotic surgery will proceed with standard open interval debulking surgery through an extended midline incision. These patients will also be followed up to assess recovery, complication rate and quality of life. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Number of patients consented compared to the number identified by multidisciplinary team as eligible for inclusion in the study expressed as a percentage. Success criteria: At least 20% of people eligible for the study will accept inclusion in the study. | Assessed at 1 year (recruitment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life following Surgery | Assessed using European Organisation for Research and Treatment of Cancer (EORTC) Validated quality of life questionnaire (QLQ) for ovarian cancer (QLQ-C30/QLQ-OV28). This validated questionnaire consists of the core module and its associated ovarian cancer specific module. | 3 months post surgery | 
| Mental wellbeing | Hospital anxiety and depression scale (HADS) A (Anxiety) and D (Depression) scores are calculated separately. 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal (case) | 3 months post surgery | 
| Pain assessment | Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain) | 3 months post surgery | 
| Surgical complications | Intraoperative complications will be recorded. Post operative complications will be recorded and classified by Clavien-Dindo Classification. Success criteria: Complication rate is not higher than for open interval debulking surgery | Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor) | 
| 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 not greater than 50% in patient group deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy. | Assessed at 1 year 3 months (once last recruited patient has undergone surgery) | 
| Robotic interval debulking - Maximal Macroscopic debulking rate (R=0 rate) | Percentage of patients undergoing robotic interval debulking surgery who achieve Maximal macroscopic debulking i.e. no macroscopic residual disease present (R=0 rate) | Assessed at 1 year 3 months (once last recruited patient has undergone surgery) | 
| Overall Survival | Measured in Months from the date of surgery. In order to follow up long-term survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee. | Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years | 
| Progression free survival | Measured in Months from the date of surgery until the date of first documented progression. In order to follow up progression free survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee. | Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years | 
| Cost | Cost of Robotic minimally invasive interval debulking surgery to the hospital compared to a similar open procedure measured in British Pound (GBP) £ | Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) |