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Trial of Neoadjuvant Chemotherapy in Locally Advanced Colon Cancer

NCT01675999 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2016-01-15

No results posted yet for this study

Summary

In patients with locally advanced colon cancer (high risk stage II and stage III), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 30-40% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery.

ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon cancer. Control arm includes patients for whom standard treatment comprises surgery followed by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most effective in terms of response rate.

Conditions

Interventions

OTHER

Perioperative simplified FOLFOX-4 chemotherapy

Preoperative chemotherapy

OTHER

Perioperative FOLFOX4+Cetuximab chemotherapy

Preoperative chemotherapy

OTHER

Surgery followed by FOLFOX4 chemotherapy

Preoperative chemotherapy

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • UNICANCER

    collaborator OTHER

  • Association de Recherche Experimentale et Clinique en Chirurgie Digestive

    collaborator OTHER

  • Association Européenne de Recherche en Oncologie

    collaborator OTHER

  • Merck Serono S.A., Geneva

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • mehdi karoui, PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-05-31
Completion
2021-02-28

Countries

  • France

Study Locations

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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 NCT01675999 on ClinicalTrials.gov