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 (NCT) | NCT00867347 |
| Protocol serial number | ICR-CTSU/2006/10002 |
| Sponsor | Institute of Cancer Research (UK) |
| Funder | Cancer Research UK (ref: C1198) |
- 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 of protocol
Contact information
Ms Rebecca Lewis
Scientific
Scientific
ICR-CTSU
Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 (0)208 722 4081 |
|---|---|
| spare-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised multicentre phase III non-inferiority study with an initial feasibility stage |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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. |
| Health condition(s) or problem(s) studied | Muscle Invasive Bladder Cancer |
| Intervention | Radical radiotherapy or radical cystectomy |
| Intervention type | Other |
| Primary outcome measure(s) |
Feasibility Study: |
| Key secondary outcome measure(s) |
1. Compliance with randomised treatment |
| Completion date | 12/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 12/02/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
ICR-CTSU
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/03/2011 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No | |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
