A multicentre, randomised trial of primary chemotherapy in inoperable cervical cancer

ISRCTN	ISRCTN26689999
DOI	https://doi.org/10.1186/ISRCTN26689999
Secondary identifying numbers	CE3003

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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: Radical pelvic radiotherapy 2. Arm B: Primary chemotherapy with bleomycin, ifosfamide and cisplatinum repeated every 28 days for two courses followed by radical pelvic radiotherapy. If after two courses of chemotherapy the measurable disease has not been reduced to <2 cm diameter and if further response is expected, then a third course of chemotherapy may be given followed by radical pelvic radiotherapy.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	bleomycin, ifosfamide, cisplatin
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1988
Completion date	31/12/1995

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	172
Key inclusion criteria	1. Histologically proven invasive squamous cell carcinoma of the cervix uteri 2. Inoperable disease, that is stage II, III or IVA. Stage IIA disease may be included if deemed inoperable by the referring gynaecologist 3. No previous treatment for invasive cervical cancer 4. World Health Organisation (WHO) performance status >2 5. Adequate renal hepatic and haematological function 6. Adequate pulmonary function 7. Patients with a probability of <0.2 of not developing severe encephalopathy with ifosfamide/mensa treatment are excluded 8. Expected survival of >3 months 9. No second primary tumour other than basal cell carcinoma of the skin 10. No other serious medical or psychological condition precluding treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1988
Date of final enrolment	31/12/1995

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