NCT01640405

Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells

Phase III, Randomized Clinical Trial to Evaluate FOLFOX + Bevacizumab Versus FOLFOXIRI + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab as first line treatment of patients with metastatic colorectal cancer not previously treated and with three or more circulating tumoral cells.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	modified FOLFOX6 + bevacizumab	* Bevacizumab 5 mg/kg iv, day 1, followed by * Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, day 1, followed by * 5- Fluorouracil (FU)/Leucovorin (LV), day 1 and 2, as follow: * LV 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 400 mg/m2 iv bolus, followed by * 5-FU 2.400 mg/m2 over 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).
DRUG	FOLFOXIRI + Bevacizumab	* Bevacizumab 5 mg/kg iv, followed by * Irinotecan 165 mg/m2 iv administered over a period of 30-90 minutes, followed by * Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, followed by * LV 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 3,200 mg/m2 for 48 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2012-07-13
• Last updated: 2019-04-11

Locations

1 site across 1 country: Spain