Ovarian Cancer Clinical Trial
— MIRRORSOfficial title:
MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
NCT number | NCT04402333 |
Other study ID # | MIRRORS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 26, 2020 |
Est. completion date | October 3, 2021 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 3, 2021 |
Est. primary completion date | October 3, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Surrey NHS Foundation Trust | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Surrey County Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Pain assessment | Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain) | 3 months post surgery | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) |
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