| Source of record | UK Trials |
| ISRCTN | ISRCTN52711596 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | CE3005 |
| Public title | A prospective randomised trial of adjuvant chemotherapy in node positive early stage carcinoma of the cervix |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Cervix |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically proven invasive adeno or squamous cell carcinoma of the cervix
2. Histologically proven pelvic lymph node involvement
3. Stage Ib or IIa disease
4. Fit to receive either treatment arm
5. Adequate renal hepatic and haematological function
6. Adequate pulmonary function
7. Patients with a probability of <0.2 of not developing severe encephalopathy with ifosfamide/mensa treatment are excluded
8. No second primary tumour other than basal cell carcinoma of the skin
9. No other serious medical or psychological condition precluding treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 28/02/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following surgery patients are randomised to either:
1. Arm A: External beam pelvic radiotherapy.
2. Arm B: Adjuvant chemotherapy plus external beam radiotherapy. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN52711596 |
| Date last extracted from ISRCTN register | 17/04/2008 |
