Know Cancer

forgot password

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

Phase 2
18 Years
70 Years
Not Enrolling
Colon Cancer, Locally Advanced Malignant Neoplasm

Thank you

Trial Information

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

See Synopsis below

Inclusion Criteria:

- Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge)

- Assessment of KRAS status of the primary colon cancer on biopsies (WT or mutated)

- Colon cancer classified: poor prognosis T3 (T3 bad) - T4 and/ or N2 by abdominal CT

- Non metastatic colon cancer (lung, liver, peritoneal)

- Non complicated primary tumor (obstruction, perforation, bleeding)

- Absence of synchronous colorectal cancer

- Age ≥ 18 years and < 71 years

- ECOG performance status 0-1

- No prior chemotherapy within the last 5 years

- No prior abdominal or pelvic irradiation within the last 5 years

- Life expectancy of 5 years or more

- No history of colorectal cancer within the last 5 years

- Patients with childbearing potential should use effective contraception during the
study and the following 6 months

- White blood cell count of 3 x 109/L or more with neutrophils of1.5 x 109/L or more,
platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more

- Total bilirubin of 1.5 x ULN (upper limit of normal) or less

- ASAT and ALAT of 2.5 x ULN or less

- Alkaline phosphatase of 1.5 x ULN or less

- Serum creatinine of 1.5 x ULN or less

- Signed written informed consent obtained prior to any study specific screening

Exclusion Criteria:

- contra-indication to iodinated contrast medium injection including allergy to
iodinated contrast medium and renal insufficiency proscribing iodinated injection

- Age > 70 years

- Rectal cancer located within 15 cm from the anal verge by endoscopy or under the
peritoneal reflection at surgery or having received radiation therapy prior to

- Complicated primary colon cancer (obstruction, bleeding, perforation)

- Synchronous colorectal cancer

- Metastatic spread at baseline assessment (lung, liver, peritoneal)

- History or current evidence on physical examination of central nervous system disease
or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events
(CTCAE) v.3.0

- Known hypersensitivity reaction to any of the components of study treatments

- Presence of inflammatory bowel disease

- HNPCC syndrome or polyposis

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to study treatment start. Incompletely healed wounds or anticipation of the
need for major surgical procedure during the course of the study

- Clinically relevant coronary artery disease or history of myocardial infarction in
the last 12 months, or high risk of uncontrolled arrhythmia

- Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period

- Previous malignancy in the last 5 years

- Medical, geographical, sociological, psychological or legal conditions that would not
permit the patient to complete the study or sign informed consent

- Any significant disease which, in the investigator's opinion, would exclude the
patient from the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histological tumor response in the primary tumor according to the simplified Tumor Regression Grade (TRG) of Ryan

Outcome Description:

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)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

mehdi karoui, PH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

January 2014

Completion Date:

February 2021

Related Keywords:

  • Colon Cancer
  • Locally Advanced Malignant Neoplasm
  • Neoadjuvant chemotherapy
  • Locally advanced malignant neoplasm
  • colon cancer
  • Neoplasms
  • Colonic Neoplasms