Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
04/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Danielle Andrews

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002490

Protocol/serial number

BS06

Study information

Scientific title

Acronym

Study hypothesis

1. To determine the efficacy of radical radiotherapy in reducing the incidence of progression of pT1G3 transitional cell carcinoma of the bladder to muscleinvasive disease and subsequent disease fatality.
2. To assess the toxicity of the radiotherapy.
3. To determine the incidence of carcinoma in situ elsewhere in the bladder and the influence of this on the subsequent clinical outcome.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer

Intervention

1. One group receives radical radiotherapy
2. The other group receives intravesical treatment with no radiotherapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1991

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. A new diagnosis of pT1G3 NXMO tumour or tumours made within 6 months of randomisation. (A prior history of bladder tumours of a lower stage or grade is admissible)
2. No history of urothelial tumours of a higher stage
3. Muscle from the base of tumour is histologically clear
4. Widespread Carcinoma In Situ (CIS) causing severe symptoms is not admissible
5. No clinical, radiological or biochemical evidence of distant metastases
6. No prior therapy with intravesical chemotherapy or BCG other than a single adjuvant treatment
7. No concomitant or previous malignancy other than non-melanomatous skin cancer or cervical intraepithelial neoplasia (CIN)
8. WHO performance status of 0-2
9. Complete resection of all tumours
10. Deemed suitable to undergo radiotherapy and cystoscopy follow-up

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1991

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

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. Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17631326

Publication citations

  1. Results

    Harland SJ, Kynaston H, Grigor K, Wallace DM, Beacock C, Kockelbergh R, Clawson S, Barlow T, Parmar MK, Griffiths GO, , A randomized trial of radical radiotherapy for the management of pT1G3 NXM0 transitional cell carcinoma of the bladder., J. Urol., 2007, 178, 3 Pt 1, 807-13; discussion 813, doi: 10.1016/j.juro.2007.05.024.

Additional files

Editorial Notes