Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Cisplatin, methotrexate and folinic acid
Primary outcome measure
Survival and time to recurrence
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/1991
Overall study end date
03/11/1995
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 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 randomised trials. Neoadjuvant Chemotherapy for Cervical Cancer Meta-analysis Collaboration (European Journal of Cancer 39 [2003] 2470-2486) - see | 01/11/2003 | Yes | No |