NCT00646607

FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,756 (actual)
• Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)	To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
DRUG	FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)	standard treatment

Timeline

• Start date: 2007-06-01
• Primary completion: 2013-04-01
• Completion: 2014-11-01
• First posted: 2008-03-28
• Last updated: 2014-11-26

Locations

111 sites across 1 country: Italy