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
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
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
end of study
No
John N. Primrose, MD
Study Chair
University Hospital Southampton NHS Foundation Trust.
UK: Medicines and Healthcare producets Regulatory Agency
CDR0000549541
NCT00482222
February 2007
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