Back to resultsSurgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
Primary Purpose
Colorectal Cancer, Metastatic Cancer
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
adjuvant therapy
conventional surgery
neoadjuvant therapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of potentially resectable colorectal liver metastases that meets one of the following criteria: Metachronous metastases after complete resection of primary tumor without gross or microscopic evidence of residual disease Synchronous metastases after complete resection of primary tumor more than 1 month before study Synchronous metastases with sufficient evidence (i.e., CAT scan or diagnostic laparoscopy) that both the primary tumor and liver metastases can be completely resected during the same procedure and resection of primary may be delayed 3-4 months PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: WHO 0-2 Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: No hepatic insufficiency Renal: Creatinine less than 2 times upper limit of normal Cardiovascular: No uncontrolled congestive heart failure or angina pectoris No hypertension or arrhythmia Other: No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer No peripheral neuropathy greater than grade 1 No prior significant neurologic or psychiatric disorders No active infection Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for advanced disease Prior adjuvant chemotherapy for primary cancer allowed unless included oxaliplatin No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer endocrine therapy Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs No concurrent investigational drugs
Sites / Locations
- Bankstown - Lidcombe Hospital
- Institute of Oncology at Prince of Wales Hospital
- Royal North Shore Hospital
- Newcastle Mater Misericordiae Hospital
- Royal Brisbane and Women's Hospital
- Princess Alexandra Hospital
- Ashford Cancer Centre
- Flinder Medical Centres
- Queen Elizabeth Hospital
- Launceston General Hospital
- Frankston Hospital
- Austin and Repatriation Medical Centre
- Mount Hospital
- Royal Perth Hospital
- Sir Charles Gairdner Hospital - Perth
- Allgemeines Krankenhaus der Stadt Wien
- Kaiser Franz Josef Hospital
- Institut Jules Bordet
- Hopital Universitaire Erasme
- Academisch Ziekenhuis der Vrije Universiteit Brussel
- Universitair Ziekenhuis Gent
- Hopital de Jolimont
- Cazk Groeninghe - Campus St-Niklaas
- U.Z. Gasthuisberg
- Centre Hospitalier - Abbeville
- Centre Hospitalier Regional et Universitaire d'Angers
- C.H.G. Beauvais
- CHR de Besancon - Hopital Jean Minjoz
- Institut Bergonie
- CHU Ambroise Pare
- C.H. Bourg En Bresse
- CMC Bligny
- CHU de Caen
- Hopital Louis Pasteur
- Centre Hospitalier Universitaire Henri Mondor
- Hopital Du Bocage
- CHU de Grenoble - Hopital de la Tronche
- Centre Hospitalier Departemental
- Clinique Du Pre
- Hopital Robert Boulin
- Centre Hospital Regional Universitaire de Limoges
- CHU de la Timone
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Hopital Lariboisiere
- Hopital Europeen Georges Pompidou
- Hopital Cochin
- C.H.G. De Pau
- Hopital Haut Leveque
- Centre Eugene Marquis
- Hopital Charles Nicolle
- Hopital Universitaire Hautepierre
- Centre Hospitalier Regional de Purpan
- CHU de Tours
- Centre Alexis Vautrin
- Hopital Paul Brousse
- Helios Klinikum Berlin
- Robert Roessle Klinik at Charite - Campus Berlin Buch im Helios Klinikum Berlin
- Knappschaft Krankenhaus
- Staedtisches Klinikum Dessau
- Medizinische Klinik I
- Department of Medicine III
- Kliniken Essen - Mitte
- Klinikum der J.W. Goethe Universitaet
- Universitaetsklinikum Freiburg
- Klinik der Justus - Leibig - Universitaet Giessen
- Klinikum der Friedrich-Schiller Universitaet Jena
- Universitaet Leipzig
- Staedtisches Klinikum Leipzig
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- Johannes Gutenberg University
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Klinikum der Universitaet Regensburg
- Caritasklinik St. Theresia
- Eberhard Karls Universitaet
- Dr. Horst-Schmidt-Kliniken
- Universitaets-Hautklinik Wuerzburg
- Prince of Wales Hospital
- Ospedale San Martino/Cliniche Universitarie Convenzionate
- Universita di Padova
- Leiden University Medical Center
- Academisch Ziekenhuis Maastricht
- Christchurch Hospital
- Haukeland Hospital - University of Bergen
- Instituto Portugues de Oncologia Centro do Porto, SA
- Sahlgrenska University Hospital
- Karolinska University Hospital/Huddinge
- Uppsala University Hospital
- North Hampshire Hospital
- Queen Elizabeth Hospital at University of Birmingham
- Bristol Haematology and Oncology Centre
- Bristol Royal Infirmary
- Addenbrooke's NHS Trust
- St. Luke's Cancer Center
- Cookridge Hospital at Leeds Teaching Hospital NHS Trust
- St. James's University Hospital
- Leicester Royal Infirmary
- Royal Liverpool and Broadgreen Hospitals
- Royal London Hospital
- Royal Free Hospital
- St. George's Hospital
- Clatterbridge Centre for Oncology NHS Trust
- Freeman Hospital
- Mount Vernon Hospital
- Queen's Medical Centre
- Royal Preston Hospital
- Weston Park Hospital
- Royal South Hants Hospital
- Southampton General Hospital
- Royal Infirmary of Edinburgh at Little France
- Ysbyty Gwynedd
- North Manchester Healthcare NHS Trust
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006479
First Posted
November 6, 2000
Last Updated
April 15, 2011
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Australasian Gastro-Intestinal Trials Group, Arbeitsgruppe Lebermetastasen und Tumoren, Cancer Research UK, Fondation Francaise de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT00006479
Brief Title
Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
Official Title
Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2000
Overall Recruitment Status
Unknown status
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Australasian Gastro-Intestinal Trials Group, Arbeitsgruppe Lebermetastasen und Tumoren, Cancer Research UK, Fondation Francaise de Cancerologie Digestive
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.
Detailed Description
OBJECTIVES:
Compare the progression-free and overall survival of patients with resectable colorectal liver metastases treated with surgery with or without neoadjuvant and adjuvant oxaliplatin, fluorouracil, and leucovorin calcium.
Compare the percentage of patients with total resection with these two treatments.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, prior adjuvant chemotherapy (yes vs no), plasma CEA level in ng/mL at diagnosis of liver metastases (5 or less vs 6 to 30 vs 31 or greater), serosa extension of primary cancer (absent T1 or T2 vs present T3 or T4), lymphatic spread of primary cancer (absent vs present N+), time interval between diagnosis of primary tumor to metastases (2 years or more vs fewer than 2 years), and number of metastases (1 to 3 vs 4). Patients are randomized to one of two treatment arms.
Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium (LV) IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2. Treatment repeats every 15 days for 6 courses in the absence of disease progression or unacceptable toxicity.
At 2 to 5 weeks after chemotherapy, patients undergo liver resection. Patients with progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks after completion of course 3 and do not receive postoperative chemotherapy.
At 2 to 5 weeks after surgery, patients receive oxaliplatin, LV, and 5-FU as in preoperative chemotherapy.
Arm II: Patients undergo liver resection. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study within 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of potentially resectable colorectal liver metastases that meets one of the following criteria:
Metachronous metastases after complete resection of primary tumor without gross or microscopic evidence of residual disease
Synchronous metastases after complete resection of primary tumor more than 1 month before study
Synchronous metastases with sufficient evidence (i.e., CAT scan or diagnostic laparoscopy) that both the primary tumor and liver metastases can be completely resected during the same procedure and resection of primary may be delayed 3-4 months
PATIENT CHARACTERISTICS:
Age:
18 to 80
Performance status:
WHO 0-2
Karnofsky 60-100%
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Hepatic:
No hepatic insufficiency
Renal:
Creatinine less than 2 times upper limit of normal
Cardiovascular:
No uncontrolled congestive heart failure or angina pectoris
No hypertension or arrhythmia
Other:
No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
No peripheral neuropathy greater than grade 1
No prior significant neurologic or psychiatric disorders
No active infection
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent biologic therapy
Chemotherapy:
No prior chemotherapy for advanced disease
Prior adjuvant chemotherapy for primary cancer allowed unless included oxaliplatin
No other concurrent chemotherapy
Endocrine therapy:
No concurrent anticancer endocrine therapy
Radiotherapy:
No concurrent radiotherapy
Surgery:
See Disease Characteristics
Other:
At least 30 days since prior investigational drugs
No concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Nordlinger, MD
Organizational Affiliation
Hopital Ambroise Pare
First Name & Middle Initial & Last Name & Degree
Euan T. Walpole, MD
Organizational Affiliation
Princess Alexandra Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wolf O. Bechstein, MD
Organizational Affiliation
Arbeitsgruppe Lebermetastasen und Tumoren
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John N. Primrose, MD
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Philippe Rougier, MD
Organizational Affiliation
Hopital Ambroise Pare
Official's Role
Study Chair
Facility Information:
Facility Name
Bankstown - Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
NSW 2200
Country
Australia
Facility Name
Institute of Oncology at Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ashford Cancer Centre
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Flinder Medical Centres
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin and Repatriation Medical Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Mount Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Sir Charles Gairdner Hospital - Perth
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Kaiser Franz Josef Hospital
City
Vienna
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Cazk Groeninghe - Campus St-Niklaas
City
Kortrijk
ZIP/Postal Code
B-8500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Hospitalier - Abbeville
City
Abbeville
ZIP/Postal Code
80101
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
C.H.G. Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
CHR de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
C.H. Bourg En Bresse
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
CMC Bligny
City
Briis Sous Forges
ZIP/Postal Code
91640
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
CHU de Grenoble - Hopital de la Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Clinique Du Pre
City
Le Mans
ZIP/Postal Code
F-72018
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
C.H.G. De Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Universitaire Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Centre Hospitalier Regional de Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Helios Klinikum Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Robert Roessle Klinik at Charite - Campus Berlin Buch im Helios Klinikum Berlin
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Knappschaft Krankenhaus
City
Bochum-Langendreer
ZIP/Postal Code
D-44892
Country
Germany
Facility Name
Staedtisches Klinikum Dessau
City
Dessau
ZIP/Postal Code
D-06822
Country
Germany
Facility Name
Medizinische Klinik I
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Department of Medicine III
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
Kliniken Essen - Mitte
City
Essen
ZIP/Postal Code
D-45136
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Klinik der Justus - Leibig - Universitaet Giessen
City
Giessen
ZIP/Postal Code
D-35385
Country
Germany
Facility Name
Klinikum der Friedrich-Schiller Universitaet Jena
City
Jena
ZIP/Postal Code
D-07740
Country
Germany
Facility Name
Universitaet Leipzig
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
Facility Name
Staedtisches Klinikum Leipzig
City
Leipzig
ZIP/Postal Code
D-04129
Country
Germany
Facility Name
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39120
Country
Germany
Facility Name
Johannes Gutenberg University
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Klinikum der Universitaet Regensburg
City
Regensburg
ZIP/Postal Code
D-93053
Country
Germany
Facility Name
Caritasklinik St. Theresia
City
Saarbrucken
ZIP/Postal Code
D-66113
Country
Germany
Facility Name
Eberhard Karls Universitaet
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Dr. Horst-Schmidt-Kliniken
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany
Facility Name
Universitaets-Hautklinik Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin, N.T.
Country
Hong Kong
Facility Name
Ospedale San Martino/Cliniche Universitarie Convenzionate
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Universita di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Haukeland Hospital - University of Bergen
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Instituto Portugues de Oncologia Centro do Porto, SA
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Sahlgrenska University Hospital
City
Gothenburg (Goteborg)
ZIP/Postal Code
S-413 45
Country
Sweden
Facility Name
Karolinska University Hospital/Huddinge
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
S-75185
Country
Sweden
Facility Name
North Hampshire Hospital
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital at University of Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
St. Luke's Cancer Center
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen Hospitals
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh at Little France
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH3 9YW
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
North Manchester Healthcare NHS Trust
City
Manchester
ZIP/Postal Code
M8 6RB
Country
United Kingdom
12. IPD Sharing Statement
Citations:
Citation
Sorbye H, Mauer M, Gruenberger T, et al.: Predictive factors for the effect of perioperative FOLFOX for resectable liver metastasis in colorectal cancer patients (EORTC phase III study 40983). [Abstract] J Clin Oncol 28 (Suppl 15): A-3544, 2010.
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Sorbye H, Mauer M, Gruenberger T, et al.: Evaluation of carcinoembryonic antigen (CEA) as a predictive baseline factor for the benefit of perioperative FOLFOX in resectable liver metastasis from colorectal cancer (EORTC study 40983). [Abstract] American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, 22-24 January 2010, Orlando, Florida. A-407, 2010.
Results Reference
result
PubMed Identifier
19554377
Citation
Benoist S, Nordlinger B. The role of preoperative chemotherapy in patients with resectable colorectal liver metastases. Ann Surg Oncol. 2009 Sep;16(9):2385-90. doi: 10.1245/s10434-009-0492-7. Epub 2009 Jun 25.
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result
PubMed Identifier
18358928
Citation
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, Collette L, Praet M, Bethe U, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet. 2008 Mar 22;371(9617):1007-16. doi: 10.1016/S0140-6736(08)60455-9.
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Citation
Julie C, Lutz MP, Aust D, et al.: Pathological analysis of hepatic injury after oxaliplatin-based neoadjuvant chemotherapy of colorectal cancer liver metastases: results of the EORTC Intergroup phase III study 40983. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-241, 2007.
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Citation
Nordlinger B, Sorbye H, Collette L, et al.: Final results of the EORTC Intergroup randomized phase III study 40983 [EPOC] evaluating the benefit of peri-operative FOLFOX4 chemotherapy for patients with potentially resectable colorectal cancer liver metastases. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA5, 2007.
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Citation
Gruenberger T, Sorbye H, Debois M, et al.: Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liver metastases (LM). Interim results of EORTC Intergroup randomized phase III study 40983. [Abstract] J Clin Oncol 24 (Suppl 18): A-3500, 2006.
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Citation
Nordlinger B, Sorbye H, Debois M, et al.: Feasibility and risks of pre-operative chemotherapy (CT) with Folfox 4 and surgery for resectable colorectal cancer liver metastases (LM). Interim results of the EORTC Intergroup randomized phase III study 40983. [Abstract] J Clin Oncol 23 (Suppl 16): A-3528, 253s, 2005.
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result
PubMed Identifier
26342674
Citation
Tanis E, Julie C, Emile JF, Mauer M, Nordlinger B, Aust D, Roth A, Lutz MP, Gruenberger T, Wrba F, Sorbye H, Bechstein W, Schlag P, Fisseler A, Ruers T. Prognostic impact of immune response in resectable colorectal liver metastases treated by surgery alone or surgery with perioperative FOLFOX in the randomised EORTC study 40983. Eur J Cancer. 2015 Nov;51(17):2708-17. doi: 10.1016/j.ejca.2015.08.014. Epub 2015 Sep 2.
Results Reference
derived
PubMed Identifier
24120480
Citation
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; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). 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 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.
Results Reference
derived
PubMed Identifier
22314329
Citation
Sorbye H, Mauer M, Gruenberger T, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Van Cutsem E, Scheithauer W, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK (CRUK); Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Predictive factors for the benefit of perioperative FOLFOX for resectable liver metastasis in colorectal cancer patients (EORTC Intergroup Trial 40983). Ann Surg. 2012 Mar;255(3):534-9. doi: 10.1097/SLA.0b013e3182456aa2.
Results Reference
derived
Learn more about this trial
Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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