A pilot randomised trial comparing short course infusional 5-Fluorouracil (5FU) with 5FU + Leucovorin as adjuvant therapy for resected colorectal carcinoma

ISRCTN ISRCTN92933910
DOI https://doi.org/10.1186/ISRCTN92933910
Secondary identifying numbers RMH E/C 920
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
11/01/2016
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 pilot randomised trial comparing short course infusional 5-Fluorouracil (5FU) with 5FU + Leucovorin as adjuvant therapy for resected colorectal carcinoma
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedColorectal carcinoma
Intervention1. 5FU (Protracted venous infusion [PVI]) 12 weeks (300 mg/m2)
2. 5FU + Folinic Acid (NCCTG) (425 mg/m2 + 20 mg/m2) every 28 days for six courses
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)5-fluorouracil, leucovorin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date19/08/1993
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Adenocarcinoma - Dukes stage B or C
2. No evidence of residual or metastatic disease assessed at surgery, clinically or radiologically
Key exclusion criteriaNot provided at time of registration
Date of first enrolment19/08/1993
Date of final enrolment31/12/2003

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

11/01/2016: no publications found on PubMed.