Overview

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

Status:
Completed
Trial end date:
2021-08-24
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang University
Treatments:
Capecitabine
Oxaliplatin
Criteria
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