Ovarian Cancer Clinical Trial
— MIRRORS-RCTPOfficial 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
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
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,
Uwins C, Read J, Tailor A, et al O041/#768 Mirrors study: a prospective cohort study assessing the feasibility of robotic interval cytoreductive surgery for advanced-stage ovarian cancer International Journal of Gynecologic Cancer 2022;32:A24.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | through study completion, an average of 1 year | |
Secondary | Blood loss | blood loss during surgery in mililitres | through study completion, an average of 1 year | |
Secondary | Maximal macroscopic cytoreduction rate (R=0 rate) | Percentage of patients undergoing MIRRORS protocol who achieve maximal macroscopic debulking i.e. no macroscopic residual disease present (R=0 rate) vs standard open interval cytoreductive surgery | through study completion, an average of 1 year | |
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 for MIRRORS protocol compared to standard open interval cytoreductive surgery. | through study completion, an average of 1 year | |
Secondary | Length of stay | Days from operation date. Operation date=day 0 | through study completion, an average of 1 year | |
Secondary | Days to chemotherapy | Days from operation date. Operation date=day 0 | through study completion, an average of 1 year | |
Secondary | Cost of MIRRORS protocol vs standard interval cytoreductive surgery | Cost comparison focusing on resources used in hospital (surgery, length of stay, readmissions, outpatients, A&E) and in the community post discharge (primary and community care). Contacts with services and professionals will be converted to costs using validated national tariffs and NHS Reference costs.
The primary health-related outcome for the economic analysis will be EQ-5D-5L, completed by participants at baseline and at each assessment point. Responses will be used to estimate the patients' health related quality of life (utility level) at each time point. This will be done by scoring the EQ-5D 5L using a validated national tariff. The utility scores will be integrated over time to provide the Quality Adjusted Life Years (QALYs), accrued by each participant over the duration of the trial. A comparison of the difference in costs and difference in QALYs over the trial period will be conducted using appropriate statistical tests to assess significance. |
through study completion, an average of 1 year | |
Secondary | Pain assessment | Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain) At baseline and post-operatively; day 1, 3, 7, 10, 14, 21, 6 weeks | through study completion, an average of 1 year | |
Secondary | Quality of life following surgery (generic) expressed as QALY gain using EQ5D-5L | At baseline and post-operatively; day 1, 3, 7, 10, 14,21,6 weeks | through study completion, an average of 1 year | |
Secondary | Quality of life following surgery (cancer specific) | Assessed using patient reported outcome measure (PROM) 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. Completed at baseline, day 3 post surgery, 3 weeks post-surgery and 6 weeks post surgery. | through study completion, an average of 1 year | |
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) Completed at baseline, day 3 post surgery, 3 weeks post-surgery and 6 weeks post surgery. | through study completion, an average of 1 year |
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