A randomised trial of combination bleomycin, ifosfamide and cisplatinum versus single agent cisplatinum in recurrent cervical cancer

ISRCTN	ISRCTN27785591
DOI	https://doi.org/10.1186/ISRCTN27785591
ClinicalTrials.gov number	NCT00003209
Secondary identifying numbers	CE3004

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cervix
Intervention	1. Arm A: Chemotherapy with single agent cisplatinum repeated every 21 days for a maximum of six courses. 2. Arm B: Multi-drug chemotherapy with bleomycin, ifosfamide and cisplatinum (BIP) repeated every 21 days for a maximum of six courses.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1990
Completion date	28/02/1996

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically proven recurrent invasive squamous cell carcinoma of the cervix uteri 2. Symptomatic inoperable pelvic or metastatic disease not amenable to local radiotherapy 3. No previous chemotherapy with any of the study agents 4. World Health Organisation (WHO) performance status >2 5. Adequate renal hepatic and haematological function 6. Adequate pulmonary function 7. Expected survival of >3 months 8. No second primary tumour other than basal cell carcinoma of the skin 9. No other serious medical or psychological condition precluding treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	28/02/1996

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2000		Yes	No