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Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00265811
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : November 9, 2020
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Folfox Drug: Cetuximab Phase 3

Detailed Description:



  • 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 years.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab
Actual Study Start Date : November 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 22, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Folfox+Cetuximab
FOLFOX-4 Cetuximab alone every 2 weeks
Drug: Folfox
Drug: Cetuximab
Active Comparator: Folfox
FOLFOX-4 alone every 2 weeks
Drug: Folfox

Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3-years DFS ]
    DFS time in the ITT KRAS wild-type population

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265811

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Hopital Duffaut
Avignon, France, 84902
CHU de Caen
Caen, France, 14033
Hopital Robert Boulin
Libourne, France, 33500
Hopital Bichat - Claude Bernard
Paris, France, 75018
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Centre Hospitalier Yves Le Foll
Saint Brieuc Cedex 1, France, BP 2367
Nouvelle Clinique Generale
Valence, France, 26000
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
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Study Chair: Julien Taieb, MD CHU Pitie-Salpetriere
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00265811    
Other Study ID Numbers: CDR0000453839
FFCD-PETACC-8 ( Other Identifier: FFCD )
2005-003463-23 ( EudraCT Number )
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federation Francophone de Cancerologie Digestive:
stage III colon cancer
adenocarcinoma of the colon
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents