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Brief Title: Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer
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
Study ID: NCT00482222
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab. Secondary * Compare the overall survival of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare the cost effectiveness of these regimens in these patients. OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms. * Neoadjuvant therapy: * Arm I: Patients receive 1 of the following chemotherapy regimens: * OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. * CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive 1 of the following regimens: * OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. * CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection. * Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy. * Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter. Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Basildon University Hospital, Basildon, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, England, United Kingdom
Royal Bournemouth Hospital, Bournemouth, England, United Kingdom
Addenbrooke's Hospital, Cambridge, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, United Kingdom
Aintree University Hospital, Liverpool, England, United Kingdom
Royal Liverpool University Hospital, Liverpool, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
UCL Cancer Institute, London, England, United Kingdom
Royal Marsden - London, London, England, United Kingdom
Charing Cross Hospital, London, England, United Kingdom
Clatterbridge Centre for Oncology, Merseyside, England, United Kingdom
St. Mary's Hospital, Newport, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Nottingham, England, United Kingdom
Dorset Cancer Centre, Poole Dorset, England, United Kingdom
Salisbury District Hospital, Salisbury, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Royal Marsden - Surrey, Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England, United Kingdom
Worthing Hospital, Worthing, England, United Kingdom
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom
University Hospital of Wales, Cardiff, Wales, United Kingdom
Name: John N. Primrose, MD
Affiliation: University Hospital Southampton NHS Foundation Trust
Role: STUDY_CHAIR