SPARE
Disease site: Urological
Treatment Modality: Radiotherapy
Status: In active follow-up
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 1015 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: | Dr Robert Huddart |
Sponsor: | Institute of Cancer Research |
Source of funding: | Cancer Research UK |
ISRCTN: | 61126465 |