| Source of record | UK Trials |
| ISRCTN | ISRCTN71172156 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LU16 |
| Public title | Randomised controlled clinical trial of oral etoposide versus intravenous multi-drug chemotherapy in the palliative treatment of patients with Small-Cell Lung Cancer (SCLC) and a poor prognosis |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Small-Cell Lung Cancer (SCLC) |
| Study hypothesis | Not provided at time of registration.
|
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Microscopically proven SCLC
2. Limited or extensive disease
3. World Health Organisation (WHO) performance status grade two, three or four
4. No previous chemotherapy, radiotherapy, or surgery for small-cell lung cancer
5. No other previous or concomitant malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix
6. No other serious condition contraindicating treatment with cytotoxic chemotherapy. Patients with evidence of liver cell damage are eligible
7. Renal function normal: plasma creatinine or urea concentration within normal limits
8. Plasma Billirubin less than 35 µmol/l
9. Any age, either sex |
| Participants - exclusion criteria | Not provided at time of registration.
|
| Patient information material |
|
| Anticipated start date | 01/08/2002 |
| Anticipated end date | 01/08/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | 1. Oral Etoposide Regimen (E): Four courses of oral etopsimide twice daily for ten days at three week intervals (i.e. ten days of chemotherapy in each three week period).
2. Intravenous Multi-Drug
Chemotherapy Regimen (EV or CAV): Clinicians chose to use one of two multi-drug chemotherapy regimens: EV: Intravenous etoposide and vincristine four courses given at three week intervals, each course given over three days according to the protocol.
CAV: Intravenous cyclophosphamide, doxorubicin and vincristine four courses given at three week intervals, each course given on one day.
All treatments should start as soon as possible after randomisation. |
| Primary outcome measure(s) | Not provided at time of registration.
|
| Secondary outcome measure(s) | Not provided at time of registration.
|
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.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 | ISRCTN71172156 |
| Date last extracted from ISRCTN register | 17/04/2008 |
