A study of the efficacy of a combination of chlorambucil and lomustine and etoposide (CLE 56) for absolute refractory prostate cancer

ISRCTN	ISRCTN50615178
DOI	https://doi.org/10.1186/ISRCTN50615178
Protocol serial number	N0020121021
Sponsor	Department of Health (UK)
Funder	Barking, Havering and Redbridge Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Jonathan Shamash
Scientific

Cancer Services
Oldchurch Hospital
Romford, Essex
RM3 0BE
United Kingdom

Phone	+44 (0)1708 517980
Email	jonathan.shamash@bartsandthelondon.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Does a combination of lomustine, chlorambucil and etoposide improve the response rate and re-exposure to hormone therapy following failure of chemotherapy will be formally assessed with re-introduction of hormones sequentially following the failure of chemotherapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Chlorambucil, lomustine and etoposide (CLE 56). If one response is seen amongst the first 14 patients the target will be increased to 23. If one or more response is seen, consideration will be given to increasing numbers to 40.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Chlorambucil, lomustine, etoposide (CLE 56)
Primary outcome measure(s)	1. To establish response rates and time to treatment failure of the regime CLE 56 2. To assess quality of life (QOL) 3. To establish effect on survival 4. To establish whether a hormone-free interval during chemotherapy leads to re-induction of endocrine therapy
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	40
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2003
Date of final enrolment	31/12/2004

Cancer Services

Romford, Essex
RM3 0BE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	17/01/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes