Randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive T2/T3 transitional cell carcinoma of the bladder: a feasibility study

ISRCTN	ISRCTN61126465
DOI	https://doi.org/10.1186/ISRCTN61126465
ClinicalTrials.gov number	NCT00867347
Secondary identifying numbers	ICR-CTSU/2006/10002

Submission date: 17/08/2006
Registration date: 22/09/2006
Last edited: 03/01/2019

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-surgery-with-treatment-that-may-help-people-to-keep-their-bladder-after-invasive-bladder-cancer

Study website

Contact information

Ms Rebecca Lewis
Scientific

ICR-CTSU
Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Phone	+44 (0)208 722 4081
Email	spare-icrctsu@icr.ac.uk

Study information

Study design	Randomised multicentre phase III non-inferiority study with an initial feasibility stage
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive T2/T3 transitional cell carcinoma of the bladder: a feasibility study
Study acronym	SPARE
Study hypothesis	Feasibility study: To determine the feasibility and patient acceptability of a multi-centre phase III randomised trial of radical cystectomy versus Selective Bladder Preservation (SBP) and to determine compliance rates with assigned treatment. Main Trial: To determine if bladder preservation is equivalent to radical cystectomy in responders to neo-adjuvant chemotherapy in terms of overall survival.
Ethics approval(s)	No ethics approval as of 18/08/2006.
Condition	Muscle Invasive Bladder Cancer
Intervention	Radical radiotherapy or radical cystectomy
Intervention type	Other
Primary outcome measure	Feasibility Study: 1. Number of patients randomised over two years 2. Proportion of patients undergoing bladder preservation in SBP arm 3. Proportion of patients undergoing cystectomy in surgery arm Main Trial: 1. Overall survival
Secondary outcome measures	1. Compliance with randomised treatment 2. Rate of salvage cystectomy after bladder preservation 3. Toxicity 4. Quality of life 5. Loco-regional progression free, metastasis free 6. Overall survival
Overall study start date	01/01/2006
Overall study end date	12/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	110 patients in the feasibility study
Participant inclusion criteria	1. Histologically confirmed Transitional Cell Carcinoma (TCC) of the bladder 2. Aged over 18 years 3. Clinical stage T2 or T3 N0 M0 (as classified by the TNM (Tumour, Nodes, Metastasis) Classification of the American Joint Committee on Cancer [AJCC]) 4. World Health Organisation (WHO) performance status zero to one 5. Fit for radical cystectomy 6. Fit for radical radiotherapy 7. Receiving/received three cycles of gemcitabine-cisplatin or other protocol approved neo-adjuvant chemotherapy regimen and willing and fit to receive a fourth cycle according to study protocol 8. Satisfactory haematological profile (at time of chemotherapy administration): a. Haemoglobin [Hb] more than 10 gms/dl b. White Blood Cells (WBC) more than 3.0 x 10^9/L c. Platelet count more than 150 x 10^9/L 9. Liver function tests (Bilirubin, Aspartate Aminotransferase [AST], Alkaline phosphatase less than 1.5 x Upper Limit of Normal [ULN]) 10. Written informed consent and available for long-term follow-up 11. Patients receiving chemotherapy are expected to have a glomerular filtration rate more than 50 ml/min though this is not part of formal inclusion criteria
Participant exclusion criteria	1. Adenocarcinoma, Squamous Cell Carcinoma (SCC), small cell carcinoma or other variant histology (N.B. squamoid differentiation or mixed TCC/SCC is permitted) 2. Widespread Carcinoma In Situ (CIS) or CIS remote from muscle invasive tumour 3. Previous malignancy in the last five years except for adequately controlled non melanotic skin tumours, CIS of cervix or Lobular Carcinoma In Situ (LCIS) of breast 4. Pre-exisiting hydronephrosis 5. Previous pelvic radiotherapy 6. Any contra-indication to radical radiotherapy e.g. inflammatory bowel disease, radiosensitivity syndrome, severe diverticular disease 7. Bilateral total hip replacements 8. Pregnancy 9. Significant co-morbid medical conditions which would interfere with administration of any protocol treatment
Recruitment start date	01/01/2006
Recruitment end date	12/02/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

ICR-CTSU

Sutton
SM2 5NG
United Kingdom

Sponsor information

Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk/
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (ref: C1198)
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	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request. Contact details are the same as in the contact information section. Clinical data are available for sharing subject to completion of a data sharing application form, approval by the trial oversight committees and completion of a data sharing agreement. As part of the review the trialists would consider whether the existing trial consent covers the application, what anonymisation will be required and whether separate ethics approval would be required.

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	15/03/2011	Yes	No
Results article	results	01/11/2017	Yes	No

Editorial Notes

03/01/2019: Plain English summary link updated, Cancer Research UK lay results summary link added to Results (plain English), trial website, publication reference and IPD sharing statement added.
06/09/2011: The overall trial end date was updated from 01/01/2016 to 12/02/2010.