Bladder CanceriROCNCT03049410
Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy
A study testing Intracorporeal Robot Assisted Radical Cystectomy and Open Radical Cystectomy in people with Bladder Cancer, run by University College, London at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Intracorporeal Robot Assisted Radical Cystectomy and Open Radical Cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 1 Mar 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
North Bristol NHS Trust
Bristol
Queen Elizabeth University Hospital
Glasgow
St James' University Hospital
Leeds
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Guy's Hospital
London
Royal Berkshire Hospital
Reading
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Lister Hospital
Stevenage
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Intracorporeal Robot Assisted Radical Cystectomy, Open Radical Cystectomy
- Keywords
- Cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal Robot Assisted Radical CystectomyProcedure or surgery
Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration
Open Radical CystectomyProcedure or surgery
Removal of bladder and adjacent organs
| Study group | Role | What they receive |
|---|---|---|
| iRARC | Active comparator | Intracorporeal Robot Assisted Radical Cystectomy Receives: Procedure: Intracorporeal Robot Assisted Radical Cystectomy |
| Open Radical Cystectomy (ORC) | Active comparator | Open Radical Cystectomy Receives: Procedure: Open Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days at home within 90 days of the surgery
To compare the number of days alive and out of hospital within 90 days from surgery.
Measured: 90 days post surgery
Secondary outcomes (2)
Difficulties due to health conditions measured using WHODAS version 2.0
To assess recovery and complications and the return to normal activities.
Measured: 12 months post surgery
Quality of Life measured using EQ-5D-5L Health Questionnaire and EORTC QLQ-C30 version 3.
To assess recovery and complications and the return to normal activities.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Mar 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kelly, Principal investigator, University College, LondonJames Catto, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049410
- Sponsor's protocol ID
- 16/0584
- Acronym
- iROC
- Status last verified
- May 2026
- First submitted
- 2 Feb 2017
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nolazco JI, Melnick KR, Lee RJ, Efstathiou JA, Feldman AS. Alternatives to radical cystectomy: a bladder-sparing approach in appropriately selected patients. BJU Int. 2026 Jul;138(1):22-32. doi: 10.1111/bju.70211. Epub 2026 Apr 16.
PubMed 41992552Dixon S, Hill H, Flight L, Khetrapal P, Ambler G, Williams NR, Brew-Graves C, Kelly JD, Catto JWF; iROC Study Team. Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer. JAMA Netw Open. 2023 Jun 1;6(6):e2317255. doi: 10.1001/jamanetworkopen.2023.17255.
PubMed 37389878Catto JWF, Khetrapal P, Ricciardi F, Ambler G, Williams NR, Al-Hammouri T, Khan MS, Thurairaja R, Nair R, Feber A, Dixon S, Nathan S, Briggs T, Sridhar A, Ahmad I, Bhatt J, Charlesworth P, Blick C, Cumberbatch MG, Hussain SA, Kotwal S, Koupparis A, McGrath J, Noon AP, Rowe E, Vasdev N, Hanchanale V, Hagan D, Brew-Graves C, Kelly JD; iROC Study Team. Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2092-2103. doi: 10.1001/jama.2022.7393.
PubMed 35569079Albisinni S, Diamand R, Mjaess G, Aoun F, Assenmacher G, Assenmacher C, Verhoest G, Holz S, Naudin M, Ploussard G, Mari A, Minervini A, Tay A, Issa R, Roumiguie M, Bajeot AS, Simone G, Anceschi U, Umari P, Sridhar A, Kelly J, Hendricksen K, Einerhand S, Sandel N, Sanchez-Salas R, Colomer A, Quackels T, Peltier A, Montorsi F, Briganti A, Teoh JYC, Pradere B, Moschini M, Roumeguere T. Defining the Morbidity of Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Adoption of the Comprehensive Complication Index. J Endourol. 2022 Jun;36(6):785-792. doi: 10.1089/end.2021.0843. Epub 2022 May 17.
PubMed 35109696Catto JWF, Khetrapal P, Ambler G, Sarpong R, Khan MS, Tan M, Feber A, Dixon S, Goodwin L, Williams NR, McGrath J, Rowe E, Koupparis A, Brew-Graves C, Kelly JD. Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study. BMJ Open. 2018 Aug 8;8(8):e020500. doi: 10.1136/bmjopen-2017-020500.
PubMed 30093510
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03049410
- Acronym / sponsor ID
- iROC / 16/0584
- Conditions
- Bladder Cancer
- Keywords
- Cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iRARC | Active comparator | Procedure: Intracorporeal Robot Assisted Radical CystectomyIntracorporeal Robot Assisted Radical Cystectomy |
| Open Radical Cystectomy (ORC) | Active comparator | Procedure: Open Radical CystectomyOpen Radical Cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracorporeal Robot Assisted Radical CystectomyIntracorporeal robot assisted radical cystoprostatectomy or anterior exenteration | Procedure or surgery | iRARC |
| Open Radical CystectomyRemoval of bladder and adjacent organs | Procedure or surgery | Open Radical Cystectomy (ORC) |
Primary outcome
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.
2 secondary outcomes
Difficulties due to health conditions measured using WHODAS version 2.0
Time frame: 12 months post surgery
Quality of Life measured using EQ-5D-5L Health Questionnaire and EORTC QLQ-C30 version 3.
Time frame: 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 41992552Nolazco JI, Melnick KR, Lee RJ, Efstathiou JA, Feldman AS. Alternatives to radical cystectomy: a bladder-sparing approach in appropriately selected patients. BJU Int. 2026 Jul;138(1):22-32. doi: 10.1111/bju.70211. Epub 2026 Apr 16.
- Derived from this study: PubMed 37389878Dixon S, Hill H, Flight L, Khetrapal P, Ambler G, Williams NR, Brew-Graves C, Kelly JD, Catto JWF; iROC Study Team. Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer. JAMA Netw Open. 2023 Jun 1;6(6):e2317255. doi: 10.1001/jamanetworkopen.2023.17255.
- Derived from this study: PubMed 35569079Catto JWF, Khetrapal P, Ricciardi F, Ambler G, Williams NR, Al-Hammouri T, Khan MS, Thurairaja R, Nair R, Feber A, Dixon S, Nathan S, Briggs T, Sridhar A, Ahmad I, Bhatt J, Charlesworth P, Blick C, Cumberbatch MG, Hussain SA, Kotwal S, Koupparis A, McGrath J, Noon AP, Rowe E, Vasdev N, Hanchanale V, Hagan D, Brew-Graves C, Kelly JD; iROC Study Team. Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2092-2103. doi: 10.1001/jama.2022.7393.
- Derived from this study: PubMed 35109696Albisinni S, Diamand R, Mjaess G, Aoun F, Assenmacher G, Assenmacher C, Verhoest G, Holz S, Naudin M, Ploussard G, Mari A, Minervini A, Tay A, Issa R, Roumiguie M, Bajeot AS, Simone G, Anceschi U, Umari P, Sridhar A, Kelly J, Hendricksen K, Einerhand S, Sandel N, Sanchez-Salas R, Colomer A, Quackels T, Peltier A, Montorsi F, Briganti A, Teoh JYC, Pradere B, Moschini M, Roumeguere T. Defining the Morbidity of Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Adoption of the Comprehensive Complication Index. J Endourol. 2022 Jun;36(6):785-792. doi: 10.1089/end.2021.0843. Epub 2022 May 17.
- Derived from this study: PubMed 30093510Catto JWF, Khetrapal P, Ambler G, Sarpong R, Khan MS, Tan M, Feber A, Dixon S, Goodwin L, Williams NR, McGrath J, Rowe E, Koupparis A, Brew-Graves C, Kelly JD. Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study. BMJ Open. 2018 Aug 8;8(8):e020500. doi: 10.1136/bmjopen-2017-020500.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kelly principal investigator
University College, London
James Catto principal investigator
University College, London
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal Robot Assisted Radical Cystectomy and Open Radical Cystectomy in people with Bladder Cancer, run by University College, London at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days at home within 90 days of the surgery (time frame: 90 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049410, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.