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Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab

Phase 3
18 Years
74 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab



- Compare the disease-free survival rates in patients with completely resected stage III
colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil
with vs without cetuximab.


- Compare the 3-year disease-free survival rate and 5-year overall survival rate in
patients treated with these regimens.

- Compare the overall survival of patients treated with these regimens.

- Compare the treatment compliance of patients treated with these regimens.

- Determine the prognostic factors and markers predictive for relapse and/or treatment
efficacy in patients treated with these regimens.

- Compare the safety of these regimens in these patients.

OUTLINE: This is an open-label, randomized, controlled, multicenter study. Patients are
stratified according to obstruction/perforation status (no obstruction and no perforation vs
obstruction and/or perforation), N stage (N1 vs N2), and T stage (T1-3 vs T4). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV
over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.

- Arm II: Patients receive chemotherapy as in arm I plus cetuximab IV over 1-2 hours on
days 1 and 8.

In both arms, treatment repeats every 14 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 5

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed stage III adenocarcinoma of the colon

- Must have undergone curative resection (R0) within the past 28-56 days

- No radiotherapy prior to surgery

- carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery

- No rectal cancer located within 15 cm from the anal verge by endoscopy or under the
peritoneal reflection at surgery

- No metastatic spread at baseline assessment

- No prior or concurrent CNS disease by physical exam


Performance status

- WHO 0-1

Life expectancy

- At least 5 years


- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL


- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 1.5 times ULN


- Creatinine ≤ 1.5 times ULN


- No coronary artery disease

- No myocardial infarction within the past 12 months

- No high risk of uncontrolled arrhythmia


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No inflammatory bowel disease

- No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix

- No significant traumatic injury within the past 28 days

- No known hypersensitivity to any of the components of the study drugs

- No medical, geographical, sociological, psychological, or legal condition that would
preclude study participation

- No peripheral neuropathy ≥ grade 1

- No other significant disease that would preclude study participation



- No prior chemotherapy


- See Disease Characteristics

- No prior abdominal or pelvic irradiation


- See Disease Characteristics

- Recovered from prior surgery

- More than 28 days since prior major surgical procedure or open biopsy

- No concurrent major surgical procedure

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

May 2012

Safety Issue:


Principal Investigator

Julien Taieb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CHU Pitie-Salpetriere


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms