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Pre and post operative chemotherapy with oxaliplatin, 5-Fluorouracil (5 FU)/Leucovorin (LV) versus surgery alone in resectable liver metastases from colorectal origin
Source of recordUK Trials
ISRCTNISRCTN55293778
Date ISRCTN assigned01/07/2001
Local reference number(s)EORTC/GITCCG 40983
Public titlePre and post operative chemotherapy with oxaliplatin, 5-Fluorouracil (5 FU)/Leucovorin (LV) versus surgery alone in resectable liver metastases from colorectal origin
Scientific title
AcronymNot Applicable
Disease/condition/study domainColon, rectum
Study hypothesisNot provided at time of registration
Design/methodologyRandomised controlled trial
Research ethics reviewNot provided at time of registration
Countries of trialUnited Kingdom
Participants - inclusion criteria1. All potentially resectable liver metastases without detectable extra-hepatic tumour
2. Primary tumour resected or resectable
3. No previous chemotherapy with oxaliplatin
Participants - exclusion criteriaNot provided at time of registration
Patient information material
Anticipated start date01/11/2000
Status of trialCompleted
Target number of participantsNot provided at time of registration
InterventionsArm A: Oxaliplatin 85 mg/m2 (day 1) 5-FU: 2000 mg/m2/cycle (days 1 and 2), Leucovorin: 200 mg/m2 (day 1 and 2), every 2 weeks for 6 cycles before surgery and for 6 cycles following surgery.
Arm B: Surgery alone.
Primary outcome measure(s)Not provided at time of registration
Secondary outcome measure(s)Not provided at time of registration
Sources of fundingCancer Research UK
Sponsor nameCancer Research UK
Sponsor detailsPO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX
Sponsor telephone+44 (0)20 7317 5186
Sponsor fax+44 (0)20 7487 4302
Sponsor emailkate.law@cancer.org.uk
Sponsor websitehttp://www.cancer.org.uk
Contact nameDr - -
Contact detailsUKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA
Contact telephone+44 (0) 20 7670 4723
Contact fax+44 (0) 20 7670 4818
Contact emailregister@ctu.mrc.ac.uk
More informationFor more up-to-date information please go to the ISRCTN link below.
Link to record in ISRCTN RegisterISRCTN55293778
Date last extracted from ISRCTN register17/04/2008
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