A Randomized Trial Investigating the Role of FOLFOX-4 Regimen Duration (3 Versus 6 Months) and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
At the present time the standard treatment for resected colon cancer with high possibility
of relapse ("high risk" stage II and all stage III) is represented by the regimen FOLFOX
(leucovorin, bolus and infusional 5fluorouracil and oxaliplatin), which is able to increase
significantly the disease-free survival (DFS) at 3 and 4 years, whereas the advantage for
5-year overall survival (OS) (which is predicted by the previous parameter) could be
observed only with a further increase of follow-up. The conventional duration of
chemotherapy is today of 6 months (12 courses every 2 weeks), but this long drug exposure
increases the risk of long-term neurotoxicity. A reduction of adjuvant chemotherapy under 6
months was proven effective in other cancers (breast, testis…) and is better tolerated by
patients in clinical practice. On the other hand, bevacizumab significantly increases OS and
all other parameters when combined with standard chemotherapy in advanced disease.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival (DFS)
time from randomization date to date of local or regional relapse
No
Roberto Labianca, MD
Principal Investigator
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Italy: The Italian Medicines Agency
2007-000354-31
NCT00646607
June 2007
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