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)
| ISRCTN | ISRCTN22342362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22342362 |
| Secondary identifying numbers | SIRON 13 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 26/03/2020
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific 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) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lung (small cell) |
| Intervention | 1. Standard chemotherapy (as per protocol) 2. Standard chemotherapy + SRL172 injections (as per protocol) |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Charity
Cancer organisations (UK)
No information available
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 | results | 01/06/2004 | 26/03/2020 | Yes | No |
Editorial Notes
26/03/2020: Publication reference added.
