A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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	Phase III
Drug / device / biological / vaccine name(s)	carbogen
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2000
Date of final enrolment	31/12/2006

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	early results	01/04/2009		Yes	No
Results article	10-year results	06/03/2021	11/03/2021	Yes	No
Plain English results			28/10/2021	No	Yes

28/10/2021: Cancer Research UK plain English results link added.
11/03/2021: Publication reference added.
27/09/2017: internal review.