Colon Cancer Clinical Trial
Official title:
PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer
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.
See Synopsis below ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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