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 |
| Secondary identifying numbers | N0020121021 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Jonathan Shamash
Scientific
Scientific
Cancer Services
Oldchurch Hospital
Romford, Essex
RM3 0BE
United Kingdom
| Phone | +44 (0)1708 517980 |
|---|---|
| jonathan.shamash@bartsandthelondon.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chlorambucil, lomustine, etoposide (CLE 56) |
| Primary outcome measure | 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 study start date | 01/02/2003 |
| Overall study end date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 40 |
| Participant inclusion criteria | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Cancer Services
Romford, Essex
RM3 0BE
United Kingdom
RM3 0BE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Barking, Havering and Redbridge Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 17/01/2005 | Yes | No |
