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Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases

NCT01508000 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-10-12

No results posted yet for this study

Summary

Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy.

There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.

The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.

It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study.

Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery

Conditions

  • Colorectal Cancer Metastatic
  • Liver Metastases
  • KRAS Wild Type Colorectal Cancer

Interventions

DRUG

FOLFOX6

5-FU, folinic acid, oxaliplatin

BIOLOGICAL

Bevacizumab

Targeted therapy

BIOLOGICAL

Panitumumab

Targeted therapy

PROCEDURE

Surgery

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Bernard Nordlinger, Pr. · C.H.U. AMBROISE PARE AP-HP, Boulogne-Billancourt, France

  • Stephane Benoist, Pr. · HOPITAL DE BICETRE AP-HP, Le Kremlin Bicetre, France

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
2013-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Austria
  • Belgium
  • France
  • Netherlands
  • Spain
  • Switzerland

Study Locations

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Entities

Drugs
Companies

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 NCT01508000 on ClinicalTrials.gov