| Protocol No.: |
NCCTG No. 147 |
| Title: |
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) After Curative Resection for Patients with Stage III Colon Cancer. |
| Staging: |
Stage III |
| Objective: |
To compare the disease-free survival in patients with stage III colon cancer that have Wild Type version K-RAS |
| Overview: |
- Histologically confirmed adenocarcinoma of the colon that has been completely resected
- At least 1 pathologically confirmed positive lymph node
- No evidence of residual involved lymph node disease
- Evidence of EGFR in resected tumor NOT required
- Patients with > one synchronous primary colon cancer are eligible
- ECOG Performance Status of 0, 1 or 2
- > 18 years of age
- No prior chemotherapy or Radiation Therapy for this malignancy
- No prior therapy with agents directed against EGFR
- All potentially eligible patients who are interested in participating in the trial will be pre-registered and a tumor sample wil be submitted to the coordinating center for K-RAS analysis.
- Normal K-RAS mutation randomization between Chemo with or without Cetuximab.
- Patients with abnormal version K-RAS will have treatment determined by physician.
|
| Eligibility Requirements: |
| No requirement |
This Protocol has Complex eligibility criteria. Please contact us for further information:
Contact Name: Debbie Reynolds, RN, OCN
Contact Phone: 386.254.4213
Contact Email: debbie.reynolds@halifax.org | |
| Contact: |
Center for Oncology
303 N. Clyde Morris Blvd.
Daytona Beach, Florida 32114
386.254.4213
Debbie Reynolds, RN, OCN
Center for Oncology
303 N. Clyde Morris Blvd.
Daytona Beach, Florida 32114
386.254.4213
Kathleen Brady, RN, BA
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