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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

NCT01640405 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2019-04-11

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Eduardo Díaz-Rubio, MD-PhD · Hospital San Carlos, Madrid

  • Enrique Aranda, MD-PhD · Hospital Reina Sofía

  • Javier Sastre, MD-PhD · Hospital San Carlos, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640405 on ClinicalTrials.gov