Condition category
Cancer
Date applied
01/05/2006
Date assigned
17/08/2006
Last edited
12/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Leyshon Griffiths

ORCID ID

Contact details

Clinical Sciences Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0) 116 258 4617
trlg1@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/Q2501/64

Study information

Scientific title

Acronym

RAPOR

Study hypothesis

Allopurinol reduces the risk of recurrence of superficial bladder cancer.

As of 24/03/2011 the anticipated end date for this trial has been updated from 01/06/2008 to 01/01/2016.

Ethics approval

Being considered for approval by the Nottingham REC 2 (reference:
UHL 9950 ETHICS 06/Q2501/64), final approval received 03/05/2006.

Study design

A single centre, randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Superficial transitional cell carcinoma of the urinary bladder

Intervention

Allopurinol 100 mg once daily with food or placebo drug

Intervention type

Drug

Phase

Phase II

Drug names

Allopurinol

Primary outcome measures

Time to biopsy-proven bladder tumour recurrence whilst taking allopurinol 100 mg once daily or placebo.

Secondary outcome measures

To evaluate the tolerability of allopurinol in patients with superficial bladder cancer, and to identify any adverse events.

Overall trial start date

01/06/2006

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with solitary Transitional Cell Carcinoma
(TCC) Ta or T1 bladder tumour (Grade one to two) that recurs at three months
2. Patients with multifocal TCC Ta bladder tumours (Grade one to two) that do not recur at three months
3. Patients with multifocal TCC Ta bladder tumours (Grade one to two) that recurs at three months

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

64 (60 at time of registration)

Participant exclusion criteria

1. Tumours with a higher risk of progression to muscle-invasive bladder cancer
2. Non-TCC bladder cancer
3. Multifocal T1 or Grade three TCC
4. Carcinoma in situ
5. More than one instillation of intravesical chemotherapy
6. Intravesical Bacillus Calmette-Guerin (BCG) therapy

Other reasons:
1. Current azathioprine or mercaptopurine treatment
2. Serum creatinine more than 200 µmol/l
3. Pregnant
4. Breast feeding
5. Aged under 18 year of age
6. Previous Allopurinol hypersensitivity
7. Current allopurinol treatment

Recruitment start date

01/06/2006

Recruitment end date

01/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Sciences Unit
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

Leicester General Hospital (UK)

Sponsor details

Department of Research and Development
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0) 116 258 4199
djr8@le.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

University Hospitals of Leicester NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes