This project consists of two independent, following specific eligibility criteria and different randomisation schemes studies, later on called DURATION study and BEV study. Once randomised in the duration study, patients fulfilling eligibility criteria for BEV study may also be randomized to receive BEV or no BEV, in addition to FOLFOX-4 chemotherapy. As both are open label studies, there will be no blinding of treatment assignment.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,756
To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
standard treatment
disease free survival (DFS)
Time frame: time from randomization date to date of local or regional relapse
overall Survival (OS), Toxicity and incidence of adverse events
Time frame: from the day of randomisation to the date of death from any cause.
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Ospedale Santo Spirito
Casale Monferrato, AL, Italy
A.O. Umberto I -Università Località Torrette
Ancona, AN, Italy
Ospedale Profili
Fabriano, AN, Italy
Ospedale Mazzoni
Ascoli Piceno, AP, Italy
Usl 11 Ospedale Murri
Fermo, AP, Italy
Università di L'Aquila
L’Aquila, AQ, Italy
ASL 8 di Arezzo
Arezzo, AR, Italy
P.O. Ospedale S.M. Della Gruccia
Montevarchi, AR, Italy
Ospedale Civile
Asti, AT, Italy
Ospedale di Altamura
Altamura, BA, Italy
...and 101 more locations