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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	14 April 2020
Main ID:	ISRCTN22342362
Date of registration:	19/08/2002
Prospective Registration:	No
Primary sponsor:	UK Co-ordinating Committee for Cancer Research (UKCCCR)
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:	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)
Date of first enrolment:	01/01/2000
Target sample size:	0
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN22342362
Study type:	Interventional
Study design:	Randomised controlled trial (Not Specified)
Phase:	Not Specified

Countries of recruitment
United Kingdom

Contacts

Name:	- -
Address:	UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road NW1 2DA London United Kingdom
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Lung (small cell)
Cancer
Lung (small cell)

Intervention(s)

1. Standard chemotherapy (as per protocol)
2. Standard chemotherapy + SRL172 injections (as per protocol)

Primary Outcome(s)

Not provided at time of registration

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

SIRON 13

Source(s) of Monetary Support

Cancer organisations (UK)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2001
URL:

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