Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGCapecitabine Oral Tablet [Xeloda]
2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w
Sponsors
Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS | through study completion, an average of 1 year | disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 2 weeks | toxicity difference of two groups |
Countries
China
Outcome results
None listed