| Source of record | UK Trials |
| ISRCTN | ISRCTN36984145 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LU12 |
| Public title | Medical Research Council Sixth Small Cell Study: A Controlled Clinical Trial of Two Policies of Chemotherapy for Poor Prognosis Patients with Small-Cell Lung Cancer (SCLC) |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lung (small cell) cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Primarily untreated microscopically confirmed SCLC
2. Age <80
3. Limited disease: poor performance status (World Health Organisation [WHO] grade 3 or 4). Extensive disease: performance status any grade
4. Renal function normal
5. Plasma Billirubin not greater than twice normal levels
6. No previous anticancer treatment for current SCLC
7. No other malignant disease (except previous basal cell carcinoma or in situ carcinoma of the cervix)
8. No other serious condition contraindicating the study regimens |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 19/08/2002 |
| Anticipated end date | 19/08/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. ECMV Regimen: Three courses three weeks apart of Etoposide, Cyclophosphamide, Methotrexate and Vincristine.
2. EV Regimen: Three courses three weeks apart of Etoposide and Vincristine. Thoracic radiotherapy and prophylactic cranial irradiation should not be given as a routine. If a patient needs radiotherapy to metastatic sites or to the primary site to control symptoms, the details should be decided by the radiotherapist and recorded as appropriate. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Reseach 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 | ISRCTN36984145 |
| Date last extracted from ISRCTN register | 17/04/2008 |
