Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
04/01/2012
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 - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00033436

Protocol/serial number

BCON

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Bladder (advanced)

Intervention

All patients receive Radiotherapy: Either 55 Gy in 20 daily fractions Or 64 Gy in 32 daily fractions. Treatments will be given daily five times per week treating all fields daily.

Patients are then randomised to:
1. Control (no further treatment)
2. Carbogen 2% CO2 (Carbogen will be delivered through a closed breathing system at a flow rate of 15 L/min of carbogen, to commence 5 min before delivery of radiation, and to commence throughout treatment) plus Nicotinamide: 60 mg/kg taken orally 1.5-2 hours before radiation.

Intervention type

Drug

Phase

Not Specified

Drug names

carbogen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2000

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Histologically proven transitional cell carcinoma of the bladder
3. Muscle invasive carcinoma (Stage T2 or T3) of any grade; G3 superficial bladder cancer (T1) or prostatic invasion T4a
4. Ability to give informed consent
5. Capable of complying with the use of a closed breathing system delivering carbogen through either a mask or a mouthpiece with nasal clip
6. No squamous or adenocarcinoma of the bladder
7. No locally advanced T4b carcinoma
8. No presence of distant metastasis or enlarged lymph nodes on Computed Tomography (CT) staging scan of the pelvis
9. No co-existing respiratory disease that contra-indicates delivery of 95% oxygen
10. No impaired renal or hepatic function
11. No ischeamic heart disease or peripheral vascular disease requiring treatment with diuretics or ACE inhibitors

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2000

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Reseach 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

1. 2009 early results in http://www.ncbi.nlm.nih.gov/pubmed/18992952

Publication citations

  1. Early results

    Hoskin PJ, Rojas AM, Saunders MI, Bentzen SM, Motohashi KJ, , Carbogen and nicotinamide in locally advanced bladder cancer: early results of a phase-III randomized trial., Radiother Oncol, 2009, 91, 1, 120-125, doi: 10.1016/j.radonc.2008.10.001.

Additional files

Editorial Notes