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

• Conditions: Ovarian Neoplasm; Ovarian Neoplasm Epithelial; Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

• Registration Number: NCT04402333
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Study Start: 2020-06-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-10-03
• Study Completion: 2021-10-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment	Assessed at 1 year (recruitment period)	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Conversion to open surgery	Assessed at 1 year 3 months (once last recruited patient has undergone 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.
Mental wellbeing	3 months post surgery	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)
Quality of Life following Surgery	3 months post 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.
Pain assessment	3 months post surgery	Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain)
Surgical complications	Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor)	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
Overall Survival	Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years	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.
Cost	Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period)	Cost of Robotic minimally invasive interval debulking surgery to the hospital compared to a similar open procedure measured in British Pound (GBP) £
Robotic interval debulking - Maximal Macroscopic debulking rate (R=0 rate)	Assessed at 1 year 3 months (once last recruited patient has undergone surgery)	Percentage of patients undergoing robotic interval debulking surgery who achieve Maximal macroscopic debulking i.e. no macroscopic residual disease present (R=0 rate)
Progression free survival	Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years	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.

Trial Locations

Locations (1)

Royal Surrey NHS Foundation Trust; 🇬🇧 Guildford, Surrey, United Kingdom