Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy (iROC)
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|ClinicalTrials.gov Identifier: NCT03049410|
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : March 14, 2019
This is a prospective multicentre randomised controlled trial comparing the outcomes from Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment of bladder cancer. The time of interest for measurement of the primary outcomes will be 90 days post-surgery.
Eligible patients will include those receiving neo-adjuvant chemotherapy (typically gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder reconstruction.
Patients who have selected radical cystectomy after appropriate counselling and following a specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to consent for this study.
Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be followed for a minimum of 90 days post-surgery.
The study will be conducted in National Health Service (NHS) Trusts designated as Cancer Centres.
Patients will be stratified by
- Type of urinary diversion (Continent diversion or ileal conduit)
- Performance status
- Centre Trial assessments will be conducted at baseline (before surgery), whilst participants are on admission and then 5, 12, 26 weeks,1 year and 18 months post surgery.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Procedure: Intracorporeal Robot Assisted Radical Cystectomy Procedure: Open Radical Cystectomy||Not Applicable|
Radical cystectomy (RC) represents the gold standard treatment for invasive bladder cancer. Reductions in morbidity and mortality from this operation have occurred in recent years through refined anaesthesia, surgical techniques, and centralization of services in high volume centres. The multimodal concept of enhanced recovery after RC (ERAS), which includes pre, intra and post operative steps, has also helped to reduce the length of stay and complications after RC further.
For most abdominal surgery, it is recognized that minimally invasive surgery is less morbid than open surgery, and produces improvements in post-operative recovery without altering the curative nature of the procedure. However, to date, there is little or conflicting evidence of any benefit from minimally invasive surgery over open surgery for RC. This may reflect the complex nature of this procedure (involving surgery to both the urinary and gastro-intestinal tracts), limitations of the current evidence or that there is no benefit. To date, three prospective trials have compared RARC with open RC (ORC). However, each has been limited by sample size and design, or their application of RARC with extra-corporeal reconstruction or have yet to report.
The investigators believe that there are no studies (reported or planned) that have compared optimal RARC (e.g. with intra-corporeal reconstruction) with optimal ORC (e.g. high volume centre using ERAS). In addition, the investigators believe none have adequately assessed the rehabilitation from RC. As such, the investigators now propose a prospective RCT to randomize eligible patients to either ORC or RARC. The investigators will focus upon measures of functional recovery and the return to normal activities.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Multicentre Randomised Controlled Trial to Compare the Efficacy of Robotically Assisted Radical Cystectomy (RARC) and Intracorporeal Urinary Diversion With Open Radical Cystectomy (ORC) in Patients With Bladder Cancer|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||February 15, 2020|
Active Comparator: iRARC
Intracorporeal Robot Assisted Radical Cystectomy
Procedure: Intracorporeal Robot Assisted Radical Cystectomy
Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration
Active Comparator: Open Radical Cystectomy (ORC)
Open Radical Cystectomy
Procedure: Open Radical Cystectomy
Removal of bladder and adjacent organs
- Days at home within 90 days of the surgery [ Time Frame: 90 days post surgery ]To compare the number of days alive and out of hospital within 90 days from surgery.
- Difficulties due to health conditions measured using WHODAS version 2.0 [ Time Frame: 12 months post surgery ]To assess recovery and complications and the return to normal activities.
- Quality of Life measured using EQ-5D-5L Health Questionnaire and EORTC QLQ-C30 version 3. [ Time Frame: 12 months post surgery ]To assess recovery and complications and the return to normal activities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049410
|Contact: Chris Brew-Graves||0207 679 firstname.lastname@example.org|
|North Bristol NHS Trust||Recruiting|
|Bristol, United Kingdom|
|Principal Investigator: Edward Rowe|
|Queen Elizabeth University Hospital||Recruiting|
|Glasgow, United Kingdom|
|Principal Investigator: Imran Ahmad|
|St James' University Hospital||Recruiting|
|Leeds, United Kingdom|
|Principal Investigator: Sanjeev Kotwal|
|University College London Hospitals NHS Foundation Trust||Recruiting|
|London, United Kingdom, NW1 2BU|
|Contact: Pramit Khetrapal email@example.com|
|Principal Investigator: Prof John Kelly|
|London, United Kingdom|
|Principal Investigator: Shamim Khan|
|Royal Berkshire Hospital||Recruiting|
|Reading, United Kingdom|
|Principal Investigator: Philip Charlesworth|
|Sheffield Teaching Hospitals NHS Foundation Trust||Recruiting|
|Sheffield, United Kingdom, S10 2JF|
|Contact: Louise Goodwin firstname.lastname@example.org|
|Principal Investigator: Prof James Catto|
|Stevenage, United Kingdom|
|Principal Investigator: Nikhil Vasdev|
|Principal Investigator:||John Kelly||University College, London|
|Principal Investigator:||James Catto||University College, London|