A multicentre, randomised trial of primary chemotherapy in inoperable cervical 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
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	bleomycin, ifosfamide, cisplatin
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1995

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2000		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes