Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. Performance status (ECOG) 0~2

2. Histologically confirmed colon cancer.

3. No prior treatment

4. CT-defined T4 or lymph node-positive colon cancer

5. Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN

6. AST and ALT < 1.5 x ULN

7. Serum creatinine ≤ 1.0 x ULN

8. Life expectancy of ≥ 3 months

9. Signed written informed consent

Exclusion Criteria:

1. Final stage with cancer cachexia

2. Allergy for capecitabine or oxaliplatin

3. Any evidence of extrahepatic metastases and/or primary tumor recurrence

4. Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC