A study of potentially curative local therapy alone, or preceded by chemotherapy, in the treatment of Stage Ib-IVa cervical carcinoma
| ISRCTN | ISRCTN79554459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79554459 |
| Secondary identifying numbers | CeCa |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 31/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Max Parmar
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| Max.parmar@ctu.mrc.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 03/11/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 313 participants intended, only 48 randomised. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1991 |
| Date of final enrolment | 03/11/1995 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| 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 |
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 |
