A randomised double-blind controlled trial of BCNU as second-line therapy in metastatic oesophago-gastric, colorectal and pancreatic cancer
| ISRCTN | ISRCTN58648476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58648476 |
| Protocol serial number | RMH E/C 1105 |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised double-blind controlled trial of BCNU as second-line therapy in metastatic oesophago-gastric, colorectal and pancreatic cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colon, oesophagus, pancreas, rectum, stomach cancers |
| Intervention | 1. Arm 1: BCNU 200 mg in 500 ml 5% dextrose 2. Arm 2: 5% dextrose alone |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | BCNU |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Any patient who has progressed on or has a short disease free interval with folinic acid modulated 5-Fluorouracil (5FU) protracted infusional 5FU regimens |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/03/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/12/2015: no publications found on PubMed.
