CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,559 enrolled
Drug / intervention
Folfox +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00265811
NCT00265811Phase 3Completed

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

Federation Francophone de Cancerologie Digestive·interventional·Posted Dec 15, 2005·Updated Nov 9, 2020

In Brief

A Phase 3 clinical trial evaluating Folfox and Cetuximab for Colorectal Cancer. Completed, enrolled 2,559 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2005
Enrollment StartNov 1, 2005
Primary CompletionNov 1, 2009
Study CompletionJun 22, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.5 years ago

Interventions

Folfoxdrug

Cetuximabdrug