Bladder cancer: Open versus Laparoscopic or RObotic cystectomy

ISRCTN	ISRCTN38528926
DOI	https://doi.org/10.1186/ISRCTN38528926
ClinicalTrials.gov number	NCT01196403
Secondary identifying numbers	SPON 568-08 (WCTU027)

Submission date: 26/09/2008
Registration date: 11/12/2008
Last edited: 21/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-different-types-of-surgery-for-bladder-cancer-bolero

Contact information

Prof John Kelly
Scientific

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

Phone	+44 (0)20 7380 9485
Email	j.d.kelly@ucl.ac.uk

Study information

Study design	Late phase II randomised multi-centre feasibility trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A study to determine the feasibility of randomisation to open versus minimal access cystectomy in patients with muscle invasive bladder cancer
Study acronym	BOLERO
Study hypothesis	Open radical cystectomy is the standard surgical approach for patients with muscle-invasive bladder cancer. Cystectomy is a complex procedure associated with post operative morbidity of 30%, and UK in-hospital mortality as high as 5.6%. Complications related to open radical cystectomy include wound infection, delay in recovery of bowel function and delay in mobilisation. As a result the UK average in-patient stay is 20 days. Minimal access radical cystectomy (laparoscopic or robotic) is emerging as an alternative to open radical cystectomy, and involves removal of the bladder through a small incision in the abdominal wall. Since the initial report more than 10 years ago, minimal access cystectomy has developed as a technique with potential for widespread application. However, there remain many unanswered questions relating to morbidity, procedure related complications, and oncological clearance. In addition, the perceived benefit of minimal access surgery by both patients and physicians may be an obstacle to recruitment into randomised controlled trials of minimal access cystectomy against the control arm of open radical surgery. BOLERO aims to test whether it is feasible to randomise patients between open or minimal access cystectomy. The secondary aims will be to assess the safety and efficacy of minimal access cystectomy, and the reasons for non-acceptance of randomisation and/or registration. Exploratory aims will include the collection of safety and toxicity data, including measures of peri-operative morbidity and surgical complications. An exploratory assessment of anatomical lymph node dissection (an indicator for oncological clearance), quality of life, and completeness of cancer surgery will also be performed. Minimal access is currently offered in each of the participating centres short-listed for this trial. Eligible patients will be identified through speciality MDTs and invited to partake in the trial. Patients will receive information describing open and minimal access cystectomy, and will be asked to consent to trial registration, and randomisation to one of two trial arms. Factors relating to a decision not to accept randomisation will be determined in a Qualitative Study. This will include qualitative assessment interviews of participants that do not agree to randomisation, and a review of screening logs to determine the reasons for non-registration. Peri-operative and in-patient exploratory assessments will be performed 6 weeks from date of discharge, then 3 monthly for 24 months. A quality of life assessment will also be performed in a subgroup of 20 participants, within 14 days of randomisation, and 4, 6 and 8 weeks, and 3, 6 and 12 months, after the date of cystectomy.
Ethics approval(s)	South East Wales Research Ethics Committee Panel D, 07/05/2010, ref: 09/WSE04/59
Condition	Invasive bladder cancer
Intervention	Arm A: Open radical cystectomy Arm B: Minimal radical cystectomy
Intervention type	Procedure/Surgery
Primary outcome measure	Feasibility of randomisation defined as >=60% of registered patients accepting randomisation to open versus minimal access cystectomy.
Secondary outcome measures	1. To determine the safety and efficacy of minimal versus open access cystectomy, including an assessment of the extent of lymph node dissection, short term morbidity and complications associated with surgery to open surgery 2. To determine the potential barriers to randomisation in patients who consent to registration and do not accept randomisation, via Quality Assessment interview of this patient pool 3. To determine potential factors relating to non-registration of patients with muscle invasive bladder cancer who are eligible for inclusion but have not been registered, based on review of screening logs Timepoints of assessment for the secondary outcome measures 1-3 above have not been finalised as of 07/10/2008. Exploratory outcome measures: 4. Morbidity assessment at 6 weeks from the date of discharge, then 3 monthly over a period of 24 months 5. Operative, peri-operative (<30 days) and late exploratory assessment (<180 days), including 90 and 180 day mortality 6. Oncological outcomes, including total number of lymph nodes resected and evidence of disease progression on CT scan at 6 and 12 months 7. Quality of life assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the muscle invasive bladder cancer module (EORTC QLQ-BLS24). Quality of life assessments will be performed in a subgroup of 20 participants, within 14 days of randomisation, 4, 6 and 8 weeks, and 3, 6 and 12 months after date of cystectomy.
Overall study start date	01/01/2009
Overall study end date	01/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	72
Participant inclusion criteria	1. Both males and females, aged >=16 years 2. American Society of Anaesthesiologists (ASA) score 1 or 2 3. Histopathological confirmation of urothelial cell carcinoma (UCC), squamous cell carcinoma (SCC) or adenocarcinoma of the bladder 4. pT1 or pT2, and mobile mass, on examination under anaesthesia 5. Computerised tomography (CT) scan of abdomen/pelvis indicating no enlarged nodes or distant metastases 6. If neo-adjuvant chemotherapy has been administered, surgery must be between 3 and 6 weeks from the last date of chemotherapy 7. Written, informed consent
Participant exclusion criteria	1. Prostatic urethral disease or upper tract disease 2. Concomitant disease that would render the patient unsuitable for the study 3. Presence of urosepsis
Recruitment start date	17/01/2011
Recruitment end date	01/02/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College Hospital

London
NW1 2BU
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Research and Commercial Division (RACD)
7th Floor
30-36 Newport Road
Cardiff
CF24 ODE
Wales
United Kingdom

Website	http://www.cf.ac.uk/racdv
"ROR"	https://ror.org/03kk7td41

Funders

Funder type

Charity

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/01/2016		Yes	No

Editorial Notes

21/01/2016: Publication reference added.
12/04/2011: the overall trial end date was changed from 31/12/2010 to 16/01/2012.