A prospective randomised trial of adjuvant chemotherapy in node positive early stage carcinoma of the cervix

ISRCTN	ISRCTN52711596
DOI	https://doi.org/10.1186/ISRCTN52711596
ClinicalTrials.gov number	NCT00003209
Secondary identifying numbers	CE3005

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

Mr - -
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	A prospective randomised trial of adjuvant chemotherapy in node positive early stage carcinoma of the 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	Following surgery patients are randomised to either: 1. Arm A: External beam pelvic radiotherapy 2. Arm B: Adjuvant chemotherapy plus external beam radiotherapy
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	01/01/1990
Completion date	28/02/1996

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically proven invasive adeno or squamous cell carcinoma of the cervix 2. Histologically proven pelvic lymph node involvement 3. Stage Ib or IIa disease 4. Fit to receive either treatment arm 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. No second primary tumour other than basal cell carcinoma of the skin 9. No other serious medical or psychological condition precluding treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	28/02/1996

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

11/04/2019: No publications found. All search options exhausted.