Additional identifiers
EudraCT 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial 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
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial 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
Patient
Age group
Adult
Gender
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
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in https://www.ncbi.nlm.nih.gov/pubmed/15151947 (added 26/03/2020)