Colorectal Cancer
Conditions
Keywords
Neoajuvant chemotherapy
Brief summary
The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.
Interventions
The neoadjuvant chemotherapy consisted of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen)
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The tumor regression grade of all the patients enrolled | from the first cycle of treatment (day one) to tumor resection |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants receiving complete tumor resection | From date of randomization until the date of the last patients receiving the surgery |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | from the first cycle of treatment (day one) to six month after the last cycle |
Countries
China
Outcome results
None listed