A randomised trial of chemotherapy and radiotherapy versus radiotherapy alone as adjuvant treatment in women with node positive operable cancer of the cervix

ISRCTN	ISRCTN54178182
DOI	https://doi.org/10.1186/ISRCTN54178182
ClinicalTrials.gov number	NCT00003209
Secondary identifying numbers	CE04

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

Ms Claire Amos
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email	abc@email.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial of chemotherapy and radiotherapy versus radiotherapy alone as adjuvant treatment in women with node positive operable cancer of the cervix
Study objectives	To compare post-operative cisplatin-based chemotherapy and radiotherapy with radiotherapy alone in patients with node positive stage IB or IIA cancer of the cervix.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cervix cancer
Intervention	1. Post-operative cisplatin-based chemotherapy and radiotherapy 2. Radiotherapy alone
Intervention type	Other
Primary outcome measure	Primary endpoint is survival, defined as time from randomisation to death (from any cause).
Secondary outcome measures	Secondary endpoints are progression-free survival, site of relapse, toxicity-free survival and quality of life.
Overall study start date	01/04/1998
Completion date	25/04/2000
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	1000
Key inclusion criteria	1. Histologically confirmed cancer of the cervix with: Squamous, adenosquamous or adencarcinoma cell type/International Federation of Gynecology and Obstetrics (FIGO) stage IB or IIA/Nodal involvement (of any extent) 2. Patient fit to receive, and with no contraindication to, cisplatin-based chemotherapy 3. Patient should have undergone a radical hysterectomy, a pelvic lymphadenectomy and resection of any suspicious (enlarged) common iliac or para-aortic lymph nodes where appropriate 4. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons 5. Written informed consent
Key exclusion criteria	1. WBC less than 3.5 x 10 to the power of 9 per litre 2. Platelets less than 100 x 10 to the power of 9 per litre 3. Bilirubin more than 1.25 times the upper limit of normal 4. Glomerular filtration rate less than 50 millilitres per minute 5. Uncontrolled or potentially active site of infection (eg fistula or abscesses)
Date of first enrolment	01/04/1998
Date of final enrolment	25/04/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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

23/01/2019: 2012 Cochrane review (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164460/ ) reported that this trial was terminated because of poor recruitment. The trial status has been changed to 'stopped'.