Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Jonathan Shamash

ORCID ID

Contact details

Cancer Services
Oldchurch Hospital
Romford
Essex
RM3 0BE
United Kingdom
+44 (0)1708 517980
jonathan.shamash@bartsandthelondon.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0020121021

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Chlorambucil, lomustine, etoposide (CLE 56)

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2003

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2003

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Services
Romford, Essex
RM3 0BE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Barking, Havering and Redbridge Hospitals NHS Trust (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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/15570307

Publication citations

  1. Results

    Shamash J, Dancey G, Barlow C, Wilson P, Ansell W, Oliver RT, Chlorambucil and lomustine (CL56) in absolute hormone refractory prostate cancer: re-induction of endocrine sensitivity an unexpected finding., Br. J. Cancer, 2005, 92, 1, 36-40, doi: 10.1038/sj.bjc.6602263.

Additional files

Editorial Notes