Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of cervix

ISRCTN	ISRCTN38929731
DOI	https://doi.org/10.1186/ISRCTN38929731
Secondary identifying numbers	G34

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

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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	Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of cervix
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 cancer
Intervention	1. Arm A: Chemotherapy with methotrexate and cisplatinum repeated every 14 days for three cycles. Radiotherapy consisting of a course of external beam therapy followed by intracavity brachytherapy to start 14 days after the third course of chemotherapy. External beam therapy, a central tumour dose of 40 Gy in twenty fractions over 4 weeks. Intracavity brachytherapy, a dose of 32.5 Gy to point A in a single insertion. 2. Arm B: Radiotherapy consisting of a course of external beam therapy followed by intracavity brachytherapy to start as soon as possible following randomisation. External beam therapy, a central tumour dose of 40 Gy in twenty fractions over 4 weeks. Intracavity brachytherapy, a dose of 32.5 Gy to point A in a single insertion.
Intervention type	Mixed
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1992
Completion date	24/08/1997

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically diagnosed squamous cell carcinoma of the cervix uteri 2. International Federation of Gynecology and Obstetrics (FIGO) stage III, IVa or bulky stage II 3. No evidence of extra pelvic spread 4. Aged <70 years 5. World Health Organisation (WHO) performance 0-2 6. Suitable for radical radiotherapy 7. Suitable for chemotherapy 8. Adequate haematological and renal function 9. No history of previous malignancy, excluding successfully treated squamous and basal cell carcinoma of skin or carcinoma in situ of the cervix 10. No previous chemotherapy or radiotherapy 11. No contraindications to treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1992
Date of final enrolment	24/08/1997

MRC Clinical Trials Unit

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