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
Secondary identifying numbers RMH E/C 1105
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised double-blind controlled trial of BCNU as second-line therapy in metastatic oesophago-gastric, colorectal and pancreatic cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedColon, oesophagus, pancreas, rectum, stomach cancers
Intervention1. Arm 1: BCNU 200 mg in 500 ml 5% dextrose
2. Arm 2: 5% dextrose alone
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)BCNU
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date31/03/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaAny 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment31/03/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

ROR logo "ROR" https://ror.org/0008wzh48

Funders

Funder type

Hospital/treatment centre

Royal Marsden Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

15/12/2015: no publications found on PubMed.