Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy

NCT03049410 | Unknown DMC

• 1 other identifier: 16/0584
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 8

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.

Conditions

Bladder Cancer

Keywords

Cystectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days post surgery

Secondary Outcomes (2)

• Difficulties due to health conditions measured using WHODAS version 2.0

  12 months post surgery

• Quality of Life measured using EQ-5D-5L Health Questionnaire and EORTC QLQ-C30 version 3.

  12 months post surgery

Study Arms (2)

iRARC

ACTIVE COMPARATOR

Intracorporeal Robot Assisted Radical Cystectomy

Procedure: Intracorporeal Robot Assisted Radical Cystectomy

Open Radical Cystectomy (ORC)

ACTIVE COMPARATOR

Open Radical Cystectomy

Procedure: Open Radical Cystectomy

Interventions

Intracorporeal Robot Assisted Radical Cystectomy PROCEDURE

Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration

iRARC

Open Radical Cystectomy PROCEDURE

Removal of bladder and adjacent organs

Open Radical Cystectomy (ORC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (8)

North Bristol NHS Trust

Bristol, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

St James' University Hospital

Leeds, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Lister Hospital

Stevenage, United Kingdom

Location

Related Publications (4)

• Dixon 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.

  PMID: 37389878 DERIVED

• Catto 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.

  PMID: 35569079 DERIVED

• Albisinni 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.

  PMID: 35109696 DERIVED

• Catto 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.

  PMID: 30093510 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• John Kelly

  University College, London

  PRINCIPAL INVESTIGATOR

• James Catto

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 10, 2017
• Study Start: March 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8)