At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the colon, stage II (T3-4 N0) or stage III (any T, N1-2)
- ✓Complete en bloc resection of tumor by open or laparoscopic colectomy (curative resection)
- ✓Tumor distal extent ≥12 cm from anal verge on endoscopy or surgical exam
- ✓ECOG performance status 0 or 1
- ✕Age <18 years
- ✕Tumor histology other than adenocarcinoma (sarcoma, lymphoma, carcinoid, etc.)
- ✕Rectal tumors (<12 cm from anal verge)
- ✕Isolated, distant, or non-contiguous intra-abdominal metastases, even if resected
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the Treatment of Patients With Resected Stages II and III Carcinoma of the Colon
In Brief
A Phase 3 clinical trial evaluating Bevacizumab, Fluorouracil, and 2 other interventions for Colon Adenocarcinoma and 6 related conditions. Completed, enrolled 2,710 participants across 1 site.
Detailed Summary
This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given IV