Condition category
Cancer
Date applied
19/04/2017
Date assigned
25/04/2017
Last edited
08/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Ms Samim Patel

ORCID ID

Contact details

Surgical & Interventional Trials Unit (SITU)
Division of Surgery & Interventional Science
Faculty of Medical Sciences
University College London
132 Hampstead Road
London
NW1 2BX
United Kingdom
+44 20 7679 9280
situ.iroc@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33071

Study information

Scientific 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

Acronym

iROC

Study hypothesis

The aim of this study is to compare robotic assisted radical cystectomy versus standard open radical cystectomy to see if one gives better recovery times and less complications than the other.

Ethics approval

NRES Committee North East – Newcastle & North Tyneside 1, 18/01/2017, ref: 16/NE/0418

Study design

Randomised; Interventional; Design type: Treatment, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Bladder Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract

Intervention

Participants are randomised in a 1:1 ratio to one of two groups.

Arm A: Participants undergo a robotically assisted radical cystectomy (RARC).
Arm B: Participants undergo a open radical cystectomy (ORC).

Patients in both groups will be followed up at 5 weeks, 12 weeks, 24 weeks and 1 year post surgery.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Number of days alive and out of hospital within 90 days from surgery is assessed by reviewing patient’s medical notes and conducting follow-up visits at 5 weeks and 12 weeks after surgery.

Secondary outcome measures

1. Self-administered WHODAS-2 (12 point) questionnaire at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery
2. Self-administered EORTC QLQ-BLM30 questionnaire at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery
3. Self-administered EQ-5D-5L questionnaire at baseline, 5 weeks, 12 weeks, 24 weeks and 1 year after surgery
4. Quantified activity levels: Total steps taken over 7 consecutive days (measured using a wearable tracking device e.g. Fitbit) at baseline (pre-operative), 5 days post-op, 5 weeks, 12 weeks, 24 weeks and 1 year after surgery
5. 30 Second Chair to Stand test: Number of times the patient can stand from sitting in a 30 second interval. This will be conducted in clinic at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery

The following tools will be used to measure complications:
Adverse events recorded using the Clavien-Dindo classification.

Overall trial start date

18/10/2016

Overall trial end date

30/11/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 04/07/2017:
1. Participants must be over 18 years of age
2. Male or female
3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
4. CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia
5. Node status ≤ N1 on imaging criteria or PET –ve outside pelvis
6. ECOG grade 0, 1, 2 or 3
7. Able to give informed written consent to participate

Previous inclusion criteria:
1. Participants must be over 18 years of age
2. Male or female
3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
4. CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia
5. Node status ≤ N1 on imaging criteria or PET –ve outside pelvis
6. ASA grade 1,2,3 or 4
7. Able to give informed written consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 320; UK Sample Size: 320

Participant exclusion criteria

Current exclusion criteria as of 04/07/2017:
1. Unwilling to undergo cystectomy
2. Previous abdominal surgery rendering them unsuitable for either iRARC or ORC
3. Patients with upper urinary tract disease
4. Concomitant disease that would render the patient unsuitable for the trial
5. Pregnant or lactating females
6. Previous radiotherapy for bladder cancer

Previous exclusion criteria:
1. Unwilling to undergo cystectomy
2. Previous abdominal surgery other than hernia repair or cholecystectomy
3. Patients with upper urinary tract disease
4. Concomitant disease that would render the patient unsuitable for the trial
5. Pregnant or lactating females

Recruitment start date

01/03/2017

Recruitment end date

30/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 20 3447 5199
randd@uclh.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The Urology Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in peer reviewed scientific journals and dissemination of the results at conference presentations and appropriate websites.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from situ.iroc@ucl.ac.uk

Intention to publish date

30/11/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.16/10/2017: Internal review. 15/09/2017: Internal review. 04/07/2017: The Royal Hallamshire Hospital has been added as a trial participating centre. The inclusion and exclusion criteria has been updated. 06/06/2017: Internal review.