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Sponsored by: |
Southampton General Hospital |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00482222 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.
Condition | Intervention | Phase |
Colorectal Cancer Metastatic Cancer |
Drug: capecitabine Drug: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables |
Phase III |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Fluorouracil Oxaliplatin Calcium gluconate Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy |
Estimated Enrollment: | 340 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* or radiologically confirmed primary adenocarcinoma of the colon or rectum
Must have potentially resectable liver metastases present, as defined by any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |||||
Addenbrooke's Hospital | Recruiting | ||||
Cambridge, England, United Kingdom, CB2 0QQ | |||||
Contact: Pippa Corrie, PhD, FRCP 44-1223-274-401 pippa.corrie@addenbrookes.nhs.uk | |||||
Aintree University Hospital | Recruiting | ||||
Liverpool, England, United Kingdom, L9 7AL | |||||
Contact: Graeme J. Poston, MD 44-151-525-5980 graeme.poston@aintree.nhs.uk | |||||
Basildon University Hospital | Recruiting | ||||
Basildon, England, United Kingdom, SS16 5NL | |||||
Contact: Pauline Leonard, MD 44-1702-435-555 | |||||
Cancer Research Centre at Weston Park Hospital | Recruiting | ||||
Nottingham, England, United Kingdom, NG5 1PB | |||||
Contact: J. Hornbuckle, MD 44-115-969-1169 ext. 47599 | |||||
Charing Cross Hospital | Recruiting | ||||
London, England, United Kingdom, W6 8RF | |||||
Contact: Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR 44-208-383-0576 charles.lowdell@imperial.nhs.uk | |||||
Royal Marsden - London | Recruiting | ||||
London, England, United Kingdom, SW3 6JJ | |||||
Contact: David Cunningham, MD 44-20-8661-3156 | |||||
North Hampshire Hospital | Recruiting | ||||
Basingstoke, England, United Kingdom, RG24 9NA | |||||
Contact: Charlotte Rees, MD 44-125-631-4793 | |||||
Poole Hospital NHS Trust | Recruiting | ||||
Poole Dorset, England, United Kingdom, BH15 2JB | |||||
Contact: Tamas Hickish, MD 44-1202-448-263 | |||||
Royal Bournemouth Hospital NHS Trust | Recruiting | ||||
Bournemouth, England, United Kingdom, BH7 7DW | |||||
Contact: Tamas Hickish, MD 44-1202-303-626 tamas.hickish@rbch.nhs.uk | |||||
Royal Liverpool University Hospital | Recruiting | ||||
Liverpool, England, United Kingdom, L9 7AL | |||||
Contact: Paula Ghaneh, MD Not Available | |||||
Clatterbridge Centre for Oncology | Recruiting | ||||
Merseyside, England, United Kingdom, CH63 4JY | |||||
Contact: David Smith, MD 44-151-334-1155 david.smith@ccotrust.nhs.uk | |||||
Royal Marsden - Surrey | Recruiting | ||||
Sutton, England, United Kingdom, SM2 5PT | |||||
Contact: David Cunningham, MD 44-20-8661-3279 david.cunningham@rmh.nhs.uk | |||||
Saint Bartholomew's Hospital | Recruiting | ||||
London, England, United Kingdom, EC1A 7BE | |||||
Contact: Sarah Slater, MD 44-20-7601-8391 | |||||
Salisbury District Hospital | Recruiting | ||||
Salisbury, England, United Kingdom, SP2 8BJ | |||||
Contact: Tim J. Iveson, MD 44-1722-336-262 ext. 4688 | |||||
Southampton General Hospital | Recruiting | ||||
Southampton, England, United Kingdom, SO16 6YD | |||||
Contact: John N. Primrose, MD 44-23-8079-6144 j.n.primrose@soton.ac.uk | |||||
Southend University Hospital NHS Foundation Trust | Recruiting | ||||
Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |||||
Contact: Pauline Leonard, MD 44-1702-435-555 | |||||
St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting | ||||
Guildford, England, United Kingdom, GU2 7XX | |||||
Contact: Sharadah Essapen, MD 44-1483-571-122 | |||||
St. Mary's Hospital | Recruiting | ||||
Newport, England, United Kingdom, PO30 5TG | |||||
Contact: Christopher Baughan, MD 44-1983-524-081 | |||||
UCL Cancer Institute | Recruiting | ||||
London, England, United Kingdom, NW3 2PF | |||||
Contact: Astrid Mayer, MD 44-207-794-0500 a.mayer@ucl.ac.uk | |||||
Worthing Hospital | Recruiting | ||||
Worthing, England, United Kingdom, BN11 2DH | |||||
Contact: Andrew Webb, MD 44-1903-205-111 | |||||
United Kingdom, Wales | |||||
University Hospital of Wales | Recruiting | ||||
Cardiff, Wales, United Kingdom, CF14 4XW | |||||
Contact: Timothy Maughan, MD 44-2920-316-904 | |||||
Velindre Cancer Center at Velindre Hospital | Recruiting | ||||
Cardiff, Wales, United Kingdom, CF14 2TL | |||||
Contact: Timothy Maughan, MD 44-2920-316-904 |
Southampton General Hospital |
Study Chair: | John N. Primrose, MD | Southampton General Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000549541, USCTU-4351, USCTU-EPOC, EUDRACT-2006-003121-82, ISRCTN22944367, EU-20732 |
First Received: | June 4, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00482222 |
Health Authority: | Unspecified |
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