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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
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be over 18 years of age.
  • Male or female
  • Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
  • CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia (see Section 22: Definitions for TNM definitions)
  • Node status ≤ N1 on imaging criteria or PET -ve outside pelvis
  • ECOG grade 0, 1, 2 or 3
  • Able to give informed written consent to participate.

Exclusion Criteria:

  • Unwilling to undergo cystectomy.
  • Previous abdominal surgery rendering them unsuitable for either iRARC or ORC.
  • Patients with upper urinary tract disease
  • Concomitant disease that would render the patient unsuitable for the trial
  • Pregnant or lactating females
  • Previous radiotherapy for bladder cancer

Information from the National Library of Medicine

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


Contacts
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Contact: Chris Brew-Graves 0207 679 9280 situ.iroc@ucl.ac.uk

Locations
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United Kingdom
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       p.khetrapal@ucl.ac.uk   
Principal Investigator: Prof John Kelly         
Guy's Hospital Recruiting
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       louise.goodwin@sth.nhs.uk   
Principal Investigator: Prof James Catto         
Lister Hospital Recruiting
Stevenage, United Kingdom
Principal Investigator: Nikhil Vasdev         
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: John Kelly University College, London
Principal Investigator: James Catto University College, London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03049410    
Other Study ID Numbers: 16/0584
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Cystectomy
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases