Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
SIRON 13
Study information
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)
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
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
Overall study end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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
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
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
31/12/2001
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Sponsor details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Sponsor type
Government
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer organisations (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2004 | 26/03/2020 | Yes | No |