SPARE is a randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive T2/T3 transitional cell carcinoma of the bladder – feasibility study.
Disease site: Urological cancer, Bladder cancer
Treatment modality: Radiotherapy
SPARE is a randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive transitional cell carcinoma of the bladder. SPARE compares the standard treatment of muscle invasive bladder cancer which is surgical removal of the bladder (cystectomy), with the new approach of selective bladder preservation.
Selective bladder preservation uses the patient’s response to neo-adjuvant chemotherapy to assess their suitability for treatment with radiotherapy. If the patient’s cancer is found to respond to three cycles of chemotherapy, they will proceed to a further cycle and then receive radical radiotherapy. If the patient’s cancer does not respond sufficiently they will proceed directly to surgery.
SPARE is randomising participants between cystectomy and selective bladder preservation. There is an initial feasibility stage to assess patient acceptability of the trial. The target sample size for the feasibility study is 110 participants, the main trial aims to recruit 1,015 participants in total.
There are a number of sub-studies associated with the main SPARE trial. The qualitative, or interview, study aims to evaluate patient response to trial information. A new qualitative sub-study has recently been initiated to examine communication between health professionals and people with invasive bladder cancer. The quality of life study will assess the impact of the randomised treatments on participants’ physical, emotional and social wellbeing. The biological samples study will examine tissue samples from surgical and biopsy specimens to investigate the biological mechanisms behind bladder cancer.
Chief Investigator: Professor Robert Huddart, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Emma Hall
Trial management contact: Rebecca Lewis - Clinical Trials Programme Manager, [email protected]
Sponsor: The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/07/011)
Further information on the SPARE trial may be found on the following sites:
View SPARE on the National Institute for Health Research website: NIHR - Be Part Of Research
Results of the SPARE trial at Cancer Research UK
Publications and presentations
Huddart RA., Birtle A, Maynard L, Beresford M, Blazeby J, Donovan J, Kelly JD, Kirkbank T, McLaren, DB, Mead G, Moynihan C, Persad R, Scrase C, Lewis R and Hall E. Clinical and patient-reported outcomes of SPARE – a randomised feasibility study of selective bladder preservation versus radical cystectomy. BJU Int. 2017;120: 639-650 doi:10.1111/bju.13900.
Moynihan C, Lewis R, Hall E, Jones E, Birtle A, Huddart R, Group STM. The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011). Trials. 2012;13:228.
Huddart R, Birtle A, Lewis R, Bahl A, Falconer A, Maynard L, Hall E. Results of the SPARE Feasibility Study – Selective Bladder Preservation Against Radical Excision in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder (CRUK/07/011). Int J Rad Oncol*Biol*Phys. 2012;84(3, Suppl):S119 #296.
Huddart R, Birtle A, Lewis R, Bahl A, Falconer A, Maynard L, Hall E, on behalf of the SPARE Trial Management Group. SPARE feasibility study - selective bladder preservation against radical excision in muscle invasive T2/T3 transitional cell carcinoma of the bladder (CRUK/07/011). NCRI National Cancer Conference; Liverpool. 2012.
Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan J. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 2011;12(78):1-15
Huddart RA, Hall E, Lewis R, Birtle A, on behalf of the SPARE Trial Management Group. Life and Death of Spare (Selective Bladder Preservation against Radical Excision): Reflections on Why the Spare Trial Closed. BJU Int. 2010;106(6):753-55
Lewis R, Huddart R, Birtle A, Blazeby J, Jones E, Hall E, on behalf of the SPARE Trial Management Group. Challenges of identifying cancer patients for randomised controlled trials (RCTs) from urology clinics - what lesson can we learn from SPARE? (CRUK/07/011). NCRI National Cancer Conference; 2009; Birmingham.
Moynihan C, Hall E, Lewis R, Birtle A, Mead GM, Huddart R, on behalf of the SPARE Trial Management Group. A qualitative study investigating barriers to randomisation in a selective bladder preservation (SBP) trial (SPARE - ISCRCTN6116465). The Institute of Cancer Research Centenary Conference; 2009; London.
Moynihan C, Hall E, Lewis R, Birtle A, Mead GM, Huddart R, on behalf of the SPARE Trial Management Group. SPARE: A qualitative study investigating randomization barriers in a Selective Bladder Preservation trial (SBP) (ISCRCTN: 61126465). J. Clin. Oncol. 2009;27(15S):5077
Moynihan C, Hall E, Lewis R, Birtle A, Mead GM, Sreenivasan R, Huddart R, on behalf of the SPARE Trial Management Group. SPARE: A qualitative study investigating randomisation barriers in a Selective Bladder Conservation trial (SBP). (ISCRCTN: 61126465; CRUK/07/011). NCRI National Cancer Conference; 2009; Birmingham.
Briggs K, Huddart R, Moynihan C, Lawrence D, Hall E, on behalf of the SPARE Protocol Development Group. Involving consumers in trial design: experiences from the proposed SPARE Trial. NCRI National Cancer Conference; 2005; Birmingham.