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

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. CONDITION: Cervix ; Cancer ; Cervix PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration 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