|
ISRCTN
|
ISRCTN55293778
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Pre and post operative chemotherapy with oxaliplatin, 5-Fluorouracil (5 FU)/Leucovorin (LV) versus surgery alone in resectable liver metastases from colorectal origin
|
|
Scientific title
|
|
|
Acronym
|
Not Applicable
|
|
Serial number at source
|
EORTC/GITCCG 40983
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Colon, rectum
|
|
Participants - inclusion criteria
|
1. All potentially resectable liver metastases without detectable extra-hepatic tumour
2. Primary tumour resected or resectable
3. No previous chemotherapy with oxaliplatin
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/11/2000
|
|
Anticipated end date
|
02/07/2004
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Added May 2008: 363
|
|
Interventions
|
1. Arm 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.
2. 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 funding
|
Cancer Research UK
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
13/05/2008
|
|
Date ISRCTN assigned
|
01/07/2001
|
