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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00006479
Registration number
NCT00006479
Ethics application status
Date submitted
6/11/2000
Date registered
27/01/2003
Date last updated
18/04/2011
Titles & IDs
Public title
Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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Scientific title
Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study
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Secondary ID [1]
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EORTC-40983
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Secondary ID [2]
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CDR0000068309
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Metastatic Cancer
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0
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Condition category
Condition code
Cancer
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2000
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Date of last participant enrolment
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Actual
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Actual
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Sample size
Target
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Bankstown - Lidcombe Hospital - Bankstown
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Institute of Oncology at Prince of Wales Hospital - Randwick
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Royal North Shore Hospital - St. Leonards
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Newcastle Mater Misericordiae Hospital - Waratah
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Royal Brisbane and Women's Hospital - Brisbane
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Princess Alexandra Hospital - Brisbane
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Ashford Cancer Centre - Ashford
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Flinder Medical Centres - Bedford Park
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Queen Elizabeth Hospital - Woodville
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Launceston General Hospital - Launceston
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Frankston Hospital - Frankston
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Austin and Repatriation Medical Centre - Heidelberg West
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Mount Hospital - Perth
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Royal Perth Hospital - Perth
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Sir Charles Gairdner Hospital - Perth - Perth
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NSW 2200 - Bankstown
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2031 - Randwick
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2065 - St. Leonards
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2298 - Waratah
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4029 - Brisbane
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4102 - Brisbane
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5035 - Ashford
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5042 - Bedford Park
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5011 - Woodville
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7250 - Launceston
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3199 - Frankston
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3081 - Heidelberg West
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6000 - Perth
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6009 - Perth
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Recruitment outside Australia
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Vienna
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Manchester
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Other
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Australasian Gastro-Intestinal Trials Group
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Other
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Arbeitsgruppe Lebermetastasen und Tumoren
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Cancer Research UK
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Fondation Francaise de Cancerologie Digestive
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00006479
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Trial related presentations / publications
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
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Bernard Nordlinger, MD
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Address
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Hopital Ambroise Pare
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Sorbye H, Mauer M, Gruenberger T, et al.: Predicti...
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Sorbye H, Mauer M, Gruenberger T, et al.: Evaluati...
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Benoist S, Nordlinger B. The role of preoperative ...
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Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Sc...
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Julie C, Lutz MP, Aust D, et al.: Pathological ana...
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Nordlinger B, Sorbye H, Collette L, et al.: Final ...
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Gruenberger T, Sorbye H, Debois M, et al.: Tumor r...
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Nordlinger B, Sorbye H, Debois M, et al.: Feasibil...
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Results not provided in
https://clinicaltrials.gov/study/NCT00006479
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