Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
01/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Claire Amos

ORCID ID

Contact details

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes