Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
31/07/2009
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

Prof Max Parmar

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Max.parmar@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CeCa

Study information

Scientific title

Acronym

Study hypothesis

This study aims to address the question of whether neo-adjuvant chemotherapy provides a survival advantage over local treatment alone in patients with cervical carcinoma.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cervical cancer

Intervention

Chemotherapy patients randomised to chemotherapy, will receive this treatment prior to local therapy. Chemotherapy will consist of: cisplatin (50 mg/m^2), methotrexate (100 mg/m^2) and folinic acid (15 mg orally every six hours, to commence 30 hours after the start of intravenous cisplatin and methotrexate, for eight doses). Cisplatin and methotrexate will be given intravenously for three cycles, once every two to three weeks depending upon tolerance. Adequate hydration should be given before and after administration of cisplatin. No immediate chemotherapy (local therapy). Because of the diversity of approach with regard to surgery and especially radiotherapy, no specific schedule will be laid down.

However all patients entering the study should receive radical local treatment which is regarded as potentially curative within that situation. Ideally, each institution should use a standard treatment policy throughout the study. Local therapy should be started as soon as possible after diagnosis or within three weeks of completing chemotherapy in those patients randomised to chemotherapy.

Intervention type

Drug

Phase

Not Specified

Drug names

Cisplatin, methotrexate and folinic acid

Primary outcome measures

Survival and time to recurrence

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1991

Overall trial end date

03/11/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven invasive cancer of the cervix Stage Ib through to IVa
2. Patients must be fit enough to receive adjuvant chemotherapy, and the chosen definitive treatment
3. World Health Organisation (WHO) performance status zero to one or creatinine clearance of at least 60 ml/min
4. The informed consent of the patient

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

313 participants intended, only 48 randomised.

Participant exclusion criteria

1. Previous chemotherapy
2. Renal, hepatic or bone marrow dysfunction which in the opinion of the investigator is sufficient to prejudice therapy (including local treatment and chemotherapy
3. Previous malignancy other than basal cell carcinoma
4. Medical or psychological conditions precluding treatment

Recruitment start date

01/01/1991

Recruitment end date

03/11/1995

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

Trial not published on its own. The results were published in the meta-analysis entitled Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Neoadjuvant Chemotherapy for Cervical Cancer Meta-analysis Collaboration (European Journal of Cancer 39 [2003] 2470-2486) - see http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14602133

Publication citations

  1. Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials., Eur. J. Cancer, 2003, 39, 17, 2470-2486.

Additional files

Editorial Notes