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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Preoperative chemotherapy
Preoperative chemotherapy
Preoperative chemotherapy
Hopital Henri Mondor
Paris, France
RECRUITINGHistological tumor response in the primary tumor according to the simplified Tumor Regression Grade (TRG) of Ryan
This primary outcome will be evaluated on the surgical specimens: Immediately after surgery (arm C) or after neoadjuvant chemotherapy (4 cycles) and surgery (arms A and B)
Time frame: 2 years
Safety and tolerability and efficacy of the neoadjuvant chemotherapy
* Tolerability of the neoadjuvant therapies. SAFETY ISSUE * Postoperative morbidity at 60 days. SAFETY ISSUE
Time frame: 9 years
•Disease free survival and regression free survival at 3 years
Time frame: 3 years
•Overall survival at 6 and 7 years
Time frame: 6 and 7 years
•Quality of life (EORTC QLQ-C30, QLQ-CR29)
Time frame: 5 years
•Quality and radicality of the surgical excision
Time frame: 2 years
•Accuracy of pre-treatment CT scan staging and evaluation of radiological response to chemotherapy
Time frame: 2 years
•Correlation between radiological and histological response
Time frame: 2 years
•Evaluation of another histopathological grade
Time frame: 2 years
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