At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed colon carcinoma, AJCC/UICC Stage II (high-risk with T4, obstruction, perforation, vascular/perineural invasion, age <50, or <12 nodes) or Stage III, tumor ≥15 cm from anal verge or above peritoneal reflection
- ✓Curative surgery performed 4-8 weeks prior to randomization
- ✓ECOG performance status 0 or 1
- ✓Life expectancy ≥5 years
- ✕Macroscopic or microscopic evidence of residual tumor or any evidence of metastatic disease (including tumor cells in ascites)
- ✕CEA >1.5 × ULN after surgery (during screening)
- ✕Prior anti-angiogenic treatment, cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
- ✕Other malignancies within last 5 years (except curatively treated basal cell carcinoma or in situ cervical carcinoma)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study
In Brief
A Phase 3 clinical trial evaluating Bevacizumab, Capecitabine, and 3 other interventions for Colorectal Cancer. Completed, enrolled 3,451 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab (Bv) may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer in adjuvant setting. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens with or without bevacizumab to compare how well they work in treating patients who have undergone surgery for high risk stage II or stage III colon cancer.
Study Details
Timeline
Interventions
Administered as an intravenous infusion over 30 - 90 minutes.
Film-coated tablets
Administered as either a bolus injection or continuous intravenous infusion over 22 hours.
Administered as a 200 mg/m\^2 infusion over 2 hours.
Administered as an intravenous infusion over 2 hours.