NCT01675999

Trial of Neoadjuvant Chemotherapy in Locally Advanced Colon Cancer

PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Detailed description

See Synopsis below

Conditions

• Colon Cancer
• Locally Advanced Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Perioperative simplified FOLFOX-4 chemotherapy	Preoperative chemotherapy
OTHER	Perioperative FOLFOX4+Cetuximab chemotherapy	Preoperative chemotherapy
OTHER	Surgery followed by FOLFOX4 chemotherapy	Preoperative chemotherapy

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-05-01
• Completion: 2021-02-01
• First posted: 2012-08-30
• Last updated: 2016-01-15

Locations

1 site across 1 country: France