Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003209
Protocol/serial number
CE04
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cervix cancer
Intervention
1. Post-operative cisplatin-based chemotherapy and radiotherapy
2. Radiotherapy alone
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/1998
Overall trial end date
25/04/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
1000
Participant 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)
Recruitment start date
01/04/1998
Recruitment end date
25/04/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary