Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC

Study Overview
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Brief Summary
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This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.

Official Title
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Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Capecitabine Oral Tablet [Xeloda]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carcinoma of the intestine confirmed histologically or cytologically Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients The ECOG PS score less than or equal to 2 points No chemotherapy of any kind has been performed in the past Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN Exclusion Criteria: Patients with unresectable CRC Patients who have any form of chemotherapy before Participating in or having participated in clinical studies of other drug Patients have second primary malignant tumors of have other malignant tumors in the past five years There is evidence of allergic reaction to drugs in this study A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias Severe active inflammation, including tuberculosis and HIV Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose Drug or alcohol addiction Get pregnant or breastfeed The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems
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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 week group<br> | Drug: Capecitabine Oral Tablet [Xeloda]<br>* 2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w<br>* Other names: oxaliplatin;|
| Active Comparator: 3 week group<br> | Drug: Capecitabine Oral Tablet [Xeloda]<br>* 2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w<br>* Other names: oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | disease free survival | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | toxicity difference of two groups | 2 weeks |