Condition category
Cancer
Date applied
17/08/2006
Date assigned
22/09/2006
Last edited
21/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Rebecca Lewis

ORCID ID

Contact details

ICR-CTSU
Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
+44 (0) 208 722 4081
spare-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00867347

Protocol/serial number

ICR-CTSU/2006/10002

Study information

Scientific title

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.

As of 06/09/2011 the end date for this trial has been updated from 01/01/2016 to 12/02/2010.

Ethics approval

No ethics approval as of 18/08/2006.

Study design

Randomised, multicentre phase III non-inferiority study with an initial feasibility stage

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Muscle Invasive Bladder Cancer

Intervention

Radical radiotherapy or radical cystectomy

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

12/02/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

110 patients in the feasibility study

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

United Kingdom

Trial participating centre

ICR-CTSU
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom
keith.snell@icr.ac.uk

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (ref: C1198)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21406089

Publication citations

  1. Results

    Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL, 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, doi: 10.1186/1745-6215-12-78.

Additional files

Editorial Notes