Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00006479
Protocol/serial number
EORTC/GITCCG 40983
Study information
Scientific title
Acronym
Not Applicable
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colon, rectum
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
oxaliplatin, 5-Fluorouracil (5 FU)/Leucovorin (LV)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2000
Overall trial end date
02/07/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added May 2008: 363
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2000
Recruitment end date
02/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24120480
Publication citations
-
Results
Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T, , , , , , Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial., Lancet Oncol., 2013, 14, 12, 1208-1215, doi: 10.1016/S1470-2045(13)70447-9.