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Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer Clinical research trials and Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer  Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
For Condition: stage 4 colon cancer,Stage 4 rectal cancer,recurrent colon cancer,liver metastases,recurrent rectal cancer
Status: Recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group , Australasian Gastro-Intestinal Trials Group,Arbeitsgruppe Lebermetastasen und tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie,Cancer Research UK,Fondation Francaise de Cancerologie Digestive
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.
Details: 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. - 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. PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BernardNordlinger, , CHU Ambroise Pare
C.H. Bourg En Bresse *Recruiting*
Bourg-en-Bresse, , 01012
France
Recruiting Contact Person Not Available
Bankstown - Lidcombe Hospital *Recruiting*
Bankstown, , NSW 2200
Australia
Recruiting Contact Person Not Available
Hopital Haut Leveque *Recruiting*
Pessac, , 33604
France
Recruiting Contact Person 33-5-5655-6565
CHU de Tours *Recruiting*
Tours, , 37044
France
Recruiting Contact Person 33-2-4747-4747
Klinikum Rechts Der Isar - Technische Universitaet Muenchen *Recruiting*
Munich, , D-81675
Germany
Recruiting Contact Person 49-89-4140
Cazk Groeninghe - Campus St-Niklaas *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-56-242-590
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-9-240-2011
Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham, England, B15 2TH
United Kingdom
Recruiting Contact Person 44-121-472-1311
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Contact Person 33-4-6761-3100
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting Matthew Seymour 44-113-392-4307
Hopital Louis Pasteur *Recruiting*
Colmar, , 68024
France
Recruiting Contact Person 33-3-8980-4102
Medizinische Klinik I *Recruiting*
Dresden, , D-01307
Germany
Recruiting Contact Person 49-351-458-4790
Institute of Oncology at Prince of Wales Hospital *Recruiting*
Randwick, New South Wales, 2031
Australia
Recruiting Contact Person 61-29-326-1798
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-52-6911
Royal Liverpool and Broadgreen Hospitals *Recruiting*
Liverpool, England, L7 8XP
United Kingdom
Recruiting Contact Person 44-0151-706-2000
Hopital Lariboisiere *Recruiting*
Paris, , 75010
France
Recruiting Contact Person 33-1-4995-6565
Christchurch Hospital *Recruiting*
Christchurch, , 1
New Zealand
Recruiting Contact Person 64-364-0020
Flinder Medical Centres *Recruiting*
Bedford Park, South Australia, 5042
Australia
Recruiting Contact Person 61-8-204-5267
Eberhard Karls Universitaet *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Contact Person 49-7071-292-711
Hopital Paul Brousse *Recruiting*
Villejuif, , 94804
France
Recruiting Contact Person 33-1-4559-3000
Hopital Europeen Georges Pompidou *Recruiting*
Paris, , 75015
France
Recruiting Contact Person 33-56-092-000
C.H.G. Beauvais *Recruiting*
Beauvais, , 60021
France
Recruiting Contact Person 33-3-4411-2121
Royal Free Hospital *Recruiting*
London, England, NW3 2QG
United Kingdom
Recruiting Contact Person 44-171-7794-0500
CMC Bligny *Recruiting*
Briis-sous-Forges, , 91640
France
Recruiting Contact Person 33-1-6490-7005
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Contact Person Not Available
Ashford Cancer Centre *Recruiting*
Ashford, South Australia, 5035
Australia
Recruiting Contact Person 61-8-351-0211
Klinikum der Universitaet Regensburg *Recruiting*
Regensburg, , D-93053
Germany
Recruiting Contact Person 49-941-7047-7110
Universitats Klinikum Freiburg *Recruiting*
Freiburg, , D-79106
Germany
Recruiting Contact Person 49-761-270-3406
St. Luke's Cancer Center *Recruiting*
Guildford, England, GU2 5XX
United Kingdom
Recruiting Clare Topham 0483-571122 ext. 6812
Clinique Du Pre *Recruiting*
Le Mans, , F-72018
France
Recruiting Contact Person Not Available
Karolinska Hospital *Recruiting*
Stockholm, , S-171 76
Sweden
Recruiting Contact Person 46-8-5177-0000
Sahlgrenska University Hospital *Recruiting*
Gothenburg (Goteborg), , S-413 45
Sweden
Recruiting Contact Person 46-31-342-22-44
Royal Brisbane and Women's Hospital *Recruiting*
Brisbane, Queensland, 4029
Australia
Recruiting Contact Person 61-73-253-8111
Mount Hospital *Recruiting*
Perth, Western Australia, 6000
Australia
Recruiting Contact Person 61-89-481-3072
CHU Ambroise Pare *Recruiting*
Boulogne-Billancourt, , F-92104
France
Recruiting Contact Person 33-1-4909-5000
Bristol Royal Infirmary *Recruiting*
Bristol, England, BS2 8HW
United Kingdom
Recruiting Contact Person 44-117-923-0000
Queen's Medical Centre *Recruiting*
Nottingham, England, NG7 2UH
United Kingdom
Recruiting Contact Person 44-115-942-1421
Klinikum der J.W. Goethe Universitaet *Recruiting*
Frankfurt, , D-60590
Germany
Recruiting Contact Person 49-69-6301-5253
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Contact Person 33-2-9925-3178
Centre Hospitalier Universitaire Henri Mondor *Recruiting*
Creteil, , 94010
France
Recruiting Contact Person 33-1-4981-2111
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Allgemeines Krankenhaus der Stadt Wien *Recruiting*
Vienna, , A-1090
Austria
Recruiting Contact Person 43-1-4040-2726
Helios Klinikum Berlin *Recruiting*
Berlin, , 13125
Germany
Recruiting Contact Person 49-30-9401-7685
Hopital Universitaire Hautepierre *Recruiting*
Strasbourg, , 67098
France
Recruiting Contact Person 33-3-8812-8000
Southampton General Hospital *Recruiting*
Southampton, England, SO16 6YD
United Kingdom
Recruiting John Primrose 44-23-8079-6144
Instituto Portugues de Oncologia Centro do Porto, SA *Recruiting*
Porto, , 4200-072
Portugal
Recruiting Contact Person 351-22-550-2011
Newcastle Mater Misericordiae Hospital *Recruiting*
Waratah, New South Wales, 2298
Australia
Recruiting Contact Person 61-2-4985-0113
Otto - Von - Guericke - Universitaet Magdeburg *Recruiting*
Magdeburg, , D-39120
Germany
Recruiting Contact Person 49-394-672-500
C.H.G. De Pau *Recruiting*
Pau, , 64000
France
Recruiting Contact Person 33-5-5992-4982
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting David Smith 44-151-334-1155
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Contact Person 33-3-8359-8400
Universita di Padova *Recruiting*
Padova, , 35128
Italy
Recruiting Contact Person 39-30-821-2055
North Manchester Healthcare NHS Trust *Recruiting*
Manchester, , M8 6RB
United Kingdom
Recruiting Contact Person 44-161-795-4567
CHU de la Timone *Recruiting*
Marseille, , 13385
France
Recruiting Contact Person 33-4-9138-6000
Johannes Gutenberg University *Recruiting*
Mainz, , D-55101
Germany
Recruiting Contact Person 49-61-1771
Klinikum der Friedrich-Schiller Universitaet Jena *Recruiting*
Jena, , D-07740
Germany
Recruiting Contact Person 49-9641-939-100
CHR de Besancon - Hopital Jean Minjoz *Recruiting*
Besancon, , 25030
France
Recruiting Anne Madroszyk 33-81-668-240
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Contact Person 31-43-387-6543
CHU de Caen *Recruiting*
Caen, , 14033
France
Recruiting Contact Person 33-23-106-3106
Uppsala University Hospital *Recruiting*
Uppsala, , S-75185
Sweden
Recruiting Bengt Glimelius 46-18-611-5513
Royal Perth Hospital *Recruiting*
Perth, Western Australia, 6000
Australia
Recruiting Contact Person 61-9-224-2244
Sir Charles Gairdner Hospital - Perth *Recruiting*
Perth, Western Australia, 6009
Australia
Recruiting Contact Person 61-8-934-63841
Dr. Horst-Schmidt-Kliniken *Recruiting*
Wiesbaden, , D-65199
Germany
Recruiting Contact Person 49-611-430
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Royal London Hospital *Recruiting*
London, England, E1 1BB
United Kingdom
Recruiting Contact Person 44-20-7377-7000
Royal Preston Hospital *Recruiting*
Preston, England, PR2 9HT
United Kingdom
Recruiting Shabbir Susnerwala 01772-522-909
Klinik der Justus - Leibig - Universitaet Giessen *Recruiting*
Giessen, , D-35385
Germany
Recruiting Contact Person Not Available
Centre Hospitalier - Abbeville *Recruiting*
Abbeville, , 80101
France
Recruiting Contact Person Not Available
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Contact Person 44-1223-245-151
Hopital Cochin *Recruiting*
Paris, , 75674
France
Recruiting Contact Person 33-1-5841-4141
Hopital de Jolimont *Recruiting*
Haine-Saint-Paul, , 7100
Belgium
Recruiting Contact Person 32-64-233-011
Freeman Hospital *Recruiting*
Newcastle upon Tyne, England, NE7 7DN
United Kingdom
Recruiting Contact Person 44-191-284-3111
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting Contact Person 44-116-254-1414
Royal Infirmary of Edinburgh at Little France *Recruiting*
Edinburgh, Scotland, EH3 9YW
United Kingdom
Recruiting Contact Person 44-31-536-1000
Royal North Shore Hospital *Recruiting*
St. Leonards, New South Wales, 2065
Australia
Recruiting Contact Person 61-2-438-7111
Department of Medicine III *Recruiting*
Erlangen, , D-91054
Germany
Recruiting Contact Person 49-9131-85-3418
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Robert Glynne-Jones 44-1923-844-012
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Contact Person 44-1702-8079-6185
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Contact Person 44-114-226-5000
Staedtisches Klinikum Dessau *Recruiting*
Dessau, , D-06822
Germany
Recruiting Contact Person 49-340-501-1214
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Contact Person 33-5-5633-3333
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 44-113-206-4904
Kliniken Essen - Mitte *Recruiting*
ESSEN, , D-45136
Germany
Recruiting Contact Person 49-201-1740
Princess Alexandra Hospital *Recruiting*
Brisbane, Queensland, 4102
Australia
Recruiting Contact Person 61-7-240-2111
Centre Hospital Regional Universitaire de Limoges *Recruiting*
Limoges, , 87042
France
Recruiting Contact Person 33-5-5505-6123
Prince of Wales Hospital *Recruiting*
Shatin, N.T., ,
Hong Kong
Recruiting Contact Person Not Available
Queen Elizabeth Hospital *Recruiting*
Woodville, South Australia, 5011
Australia
Recruiting Contact Person 61-8-2436645
Caritasklinik St. Theresia *Recruiting*
Saarbrucken, , D-66113
Germany
Recruiting Contact Person 49-681-406-1101
North Hampshire Hospital *Recruiting*
Basingstoke, England, RG24 9NA
United Kingdom
Recruiting Contact Person 44-1256-31-4793
Hopital Du Bocage *Recruiting*
Dijon, , 21034
France
Recruiting Contact Person 33-3-8029-3031
Hopital Charles Nicolle *Recruiting*
Rouen, , 76031
France
Recruiting Contact Person 33-2-3508-8247
Staedtisches Klinikum Leipzig *Recruiting*
Leipzig, , D-04129
Germany
Recruiting Contact Person Not Available
Ysbyty Gwynedd *Recruiting*
Bangor, Wales, LL57 2PW
United Kingdom
Recruiting Nick Stuart 44-0124-3841-50
Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon, , F-85025
France
Recruiting Contact Person 33-2-5144-6112
Robert Roessle Klinik *Recruiting*
Berlin, , D-13122
Germany
Recruiting Contact Person 49-30-9417-1492
St. George's Hospital *Recruiting*
London, England, SW17 0QT
United Kingdom
Recruiting Contact Person 44-20-8672-1255
Centre Hospitalier Regional de Purpan *Recruiting*
Toulouse, , 31059
France
Recruiting Contact Person 33-61-491-133
Centre Hospitalier Regional et Universitaire d'Angers *Recruiting*
Angers, , 49033
France
Recruiting Contact Person 33-2-4148-1066
Hopital Robert Boulin *Recruiting*
Libourne, , 33500
France
Recruiting Contact Person 33-5-5755-3434
Haukeland Hospital - University of Bergen *Recruiting*
Bergen, , N-5021
Norway
Recruiting Contact Person 47-972-010
Knappschaft Krankenhaus *Recruiting*
Bochum-Langendreer, , D-44892
Germany
Recruiting Contact Person 49-234-2990
Ospedale San Martino/Cliniche Universitarie Convenzionate *Recruiting*
Genoa (Genova), , 16132
Italy
Recruiting Contact Person 39-10-560-0665
Frankston Hospital *Recruiting*
Frankston, Victoria, 3199
Australia
Recruiting Contact Person 61-03-9784-7777
Universitaets-Hautklinik Wuerzburg *Recruiting*
Wuerzburg, , D-97080
Germany
Recruiting Contact Person 49-931-201-2728
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-2-555-3111
Academisch Ziekenhuis der Vrije Universiteit Brussel *Recruiting*
Brussels, , 1090
Belgium
Recruiting Contact Person 32-2-477-6040
Austin and Repatriation Medical Centre *Recruiting*
Heidelberg West, Victoria, 3081
Australia
Recruiting Contact Person 61-3-9496-5000
CHU de Grenoble - Hopital de la Tronche *Recruiting*
Grenoble, , 38043
France
Recruiting Contact Person 33-4-7676-7575
Launceston General Hospital *Recruiting*
Launceston, Tasmania, 7250
Australia
Recruiting Contact Person 61-3-327-111
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Meg Finch-Jones 44-117-928-2412
Additional Information:
Study ID Numbers: CDR0000068309; ALM-CAO-EORTC-40983,EU-20048,EORTC-40983,CRC-EORTC-40983,AGITG-EORTC-40983,CRUK-LON-EORTC-40983,FFCD-EORTC-40983
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006479
Other Recurrent Rectal Cancer Studies:
1. Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
2. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
3. Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
4. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
5. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
Related Studies:
Other recurrent rectal cancer Clinical Trials
Other Clinical Trials
Other Frankfurt Clinical Trials
Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
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