Ovarian cancer Cancer Malignant neoplasm of ovary
Conditions
Interventions
The researchers are looking to find out in women with advanced ovarian cancer who have received chemotherapy before surgery whether robotic surgery is able to remove as much tumour as open surgery wit
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Adult women =18 years with stage III and IV ovarian cancer undergoing neoadjuvant chemotherapy 2. Considered suitable for IDS 3. =8 cm pelvic mass 4. Open surgery not required for other surgical speciality intervention MIRRORS ICG inclusion criteria - same as above
Exclusion criteria
Exclusion criteria: 1. Extensive disease requiring liver and upper gastro-intestinal surgical support will exclude patients if an open surgical approach is considered necessary 2. Lacking capacity to the extent they are unable to understand or complete trial documentation/questionnaires MIRRORS ICG exclusion criteria: Severe renal insufficiency GFR <55 ml/min, known allergy to iodine or ICG and hyperthyroidism
Design outcomes
Primary
| Measure | 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. Assessed at 1 year (recruitment period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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) at baseline, Day 1 post op, 3-4 weeks post op, 3months +/- 7 days post op 2. Mental wellbeing assessed using hospital anxiety and depression scale (HADS) at baseline, Day 1 post op, 3-4 weeks post op, 3months +/- 7 days post op 3. Pain assessed using a numeric rating scale (NRS11) at baseline, Day 1 post op, 3-4 weeks post op, 3months +/- 7 days post op 4. Surgical complications from quarterly reports submitted to sponsor assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period) 5. 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), assessed at 1 year 3 months (once the last recruited patient has undergone surgery) 6. Robotic interval debulking maximal macroscopic debulking rate (R=0) (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) 7. Overall survival, measured in months from the date of surgery, assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period), reassessed at 5 years to a maximum of 10 years 8. Progression-free survival, measured in months from the date of surgery until the date of first documented progression, assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period) reassessed at 5 years to a maximum of 10 years 9. Cost of robotic minimally invasive interval debulking surgery to the hospital compared to a similar open | — |
Countries
England, United Kingdom
Outcome results
None listed