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

NCT00646607 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3756

Last updated 2014-11-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

    lead OTHER

Principal Investigators

  • Roberto Labianca, MD · Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

  • Alberto Sobrero, MD · Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2013-04-30
Completion
2014-11-30

Countries

  • Italy

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 NCT00646607 on ClinicalTrials.gov