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

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine plus oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Performance status (ECOG) 0 2 Histologically confirmed colon cancer. No prior treatment CT-defined T4 or lymph node-positive colon cancer Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN AST and ALT < 1.5 x ULN Serum creatinine ≤ 1.0 x ULN Life expectancy of ≥ 3 months Signed written informed consent Exclusion Criteria: Final stage with cancer cachexia Allergy for capecitabine or oxaliplatin Any evidence of extrahepatic metastases and/or primary tumor recurrence 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant chemotherapy<br>A total of 55 cases of locally advanced colon cancer will be enrolled in this arm. After radiological staging, patients were treated first with 3 cycles of neoadjuvant chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by tumor resection, and then with another 5 cycles of adjuvant chemotherapy with the XELOX regimen. Radiological response was evaluated after 2 cycles of neoadjuvant chemotherapy . A total of 3 cycles neoadjuvant chemotherapy was completed unless there was unacceptable toxicity, emergency operation condition or tumor progression during the period. Tumor responses, toxicities, and surgical complications were recorded. The pathological tumor response in the primary tumor was evaluated according to tumor regression grade (TRG) score. | Drug: capecitabine plus oxaliplatin<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The tumor regression grade of all the patients enrolled |  | from the first cycle of treatment (day one) to tumor resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoajuvant chemotherapy