| Source of record | UK Trials |
| ISRCTN | ISRCTN22342362 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | SIRON 13 |
| Public title | An open randomised study of the efficacy of standard radiotherapy with and without the addition of SRL172 (Mycobacterium vaccae) in the treatment of patients with small cell lung cancer (SIRON 13) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung (small cell) |
| 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. Patients should be aged at least 18 years with histologically and/or cytologically confirmed unresectable small cell lung cancer, which includes limited or extensive stage disease
2. There should be presence of measurable or evaluable disease
3. Patients should be World Health Organisation (WHO) performance status 0-2
4. Serum creatinine <140 micromol/l or creatinine clearance >50 ml/min (if serum creatinine 120-140 micromol/l) if receiving cisplatin. If receiving carboplatin, creatinine clearance >20ml/min
5. Life expectance >3 months
6. Written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Standard chemotherapy (as per protocol)
2. Standard chemotherapy + SRL172 injections (as per protocol) |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| 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 | ISRCTN22342362 |
| Date last extracted from ISRCTN register | 17/04/2008 |
