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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
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
详细描述
Hypothesis: in selected cases of epithelial ovarian cancer (EOC), following neoadjuvant chemotherapy, robotic surgery is safe and acceptable, facilitates maximal debulking surgery and is associated with improved patient outcomes.
MIRRORS- RCT Pilot is a Randomised controlled trial (RCT) to establish whether; the MIRRORS protocol can operate successfully as an RCT at other sites, that patients are willing to be recruited and randomised, before commencing a national multicentre trial. The aim is to provide proof of the concept that a larger adequately powered multi-centre RCT is feasible.
All Women with Stage 3c or greater EOC with a pelvic mass ≤8cm will be identified at diagnosis from the first MDT discussion. All patients will have a CT at presentation which will be used to screen women as suitable or not for inclusion. Potential eligible participants will be offered inclusion and provided with a participant information leaflet and study consent form to consider for at least 24 hours prior to review in clinic. Participants opting to participate will then undergo the consent process. They will sign the study consent form following discussion and have the opportunity to ask any questions they wish. This consent process will be carried out with an experienced member of the clinical team who is authorised, trained and competent to do so. Participants will then be asked to complete baseline questionnaires.
All screened patients will have the following anonymised basic information collected: date of birth, age, ethnicity, reason not eligible and reason for declining if eligible but declined.
Participants found to have progressive disease will not be offered cytoreductive surgery and will then be excluded from the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Recruitment
时间窗: Assessed at close of recruitment 6-8 months (recruitment period)
Number of patients consented compared to the number offered inclusion expressed as a percentage.
次要结局
- Days to chemotherapy(through study completion, an average of 1 year)
- Rate of conversion to open surgery(through study completion, an average of 1 year)
- Maximal macroscopic cytoreduction rate (R=0 rate)(through study completion, an average of 1 year)
- Surgical complications(through study completion, an average of 1 year)
- Cost of MIRRORS protocol vs standard interval cytoreductive surgery(through study completion, an average of 1 year)
- Quality of life following surgery (generic) expressed as QALY gain using EQ5D-5L(through study completion, an average of 1 year)
- Blood loss(through study completion, an average of 1 year)
- Length of stay(through study completion, an average of 1 year)
- Pain assessment(through study completion, an average of 1 year)
- Mental wellbeing(through study completion, an average of 1 year)
- Quality of life following surgery (cancer specific)(through study completion, an average of 1 year)
研究者
Miss Christina Uwins
Sub-Speciality Fellow in Gynaecological Oncology and Associate PI
Royal Surrey County Hospital NHS Foundation Trust