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Sponsored by: |
Federation Francophone de Cancerologie Digestive |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00265811 |
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 | Intervention | Phase |
Colorectal Cancer |
Drug: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy |
Phase III |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin Calcium gluconate Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab |
Estimated Enrollment: | 2000 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone curative resection (R0) within the past 28-56 days
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
France | |||||
Centre Hospitalier Yves Le Foll | Recruiting | ||||
Saint Brieuc Cedex 1, France, BP 2367 | |||||
Contact: Corinne Alleaume 33-2-9601-7123 | |||||
CHU de Caen | Recruiting | ||||
Caen, France, 14033 | |||||
Contact: Dominique Arsene 33-2-3106-4514 | |||||
CHU Pitie-Salpetriere | Recruiting | ||||
Paris, France, 75651 | |||||
Contact: Julien Taieb, MD 33-1-4216-1023 | |||||
Hopital Bichat - Claude Bernard | Recruiting | ||||
Paris, France, 75018 | |||||
Contact: Thomas Aparicio 33-1-4025-7200 thomas.aparicio@bch.ap-hop-paris.fr | |||||
Nouvelle Clinique Generale | Recruiting | ||||
Valence, France, 26000 | |||||
Contact: Philippe Amoyal, MD 33-4-7578-2466 philippe.amoyal@wanadoo.fr | |||||
Hopital Robert Boulin | Recruiting | ||||
Libourne, France, 33500 | |||||
Contact: Dominique Auby 33-5-5755-3552 dominique.auby@cheibourne.aquisante.fr | |||||
Hopital Tenon | Recruiting | ||||
Paris, France, 75970 | |||||
Contact: Xavier Amiot 33-1-4030-7000 | |||||
Hopital Duffaut | Recruiting | ||||
Avignon, France, 84902 | |||||
Contact: Ahmed Azzedine 33-4-3275-3121 |
Federation Francophone de Cancerologie Digestive |
Study Chair: | Julien Taieb, MD | CHU Pitie-Salpetriere |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000453839, FFCD-PETACC-8, EU-20547, EUDRACT-2005-003463-23, PETACC-8, MERCK-FFCD-PETACC-8 |
First Received: | December 14, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00265811 |
Health Authority: | Unspecified |
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