Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
29/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

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

  1. 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.

Additional files

Editorial Notes