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

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Capecitabine Oral Tablet [Xeloda]

• Registration Number: NCT03564912
• Lead Sponsor: Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-21
• Study Start: 2018-08-12
• Status Verified: 2021-08
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 week group	Capecitabine Oral Tablet [Xeloda]	-
3 week group	Capecitabine Oral Tablet [Xeloda]	-

Primary Outcome Measures

Name	Time	Method
DFS	through study completion, an average of 1 year	disease free survival

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	2 weeks	toxicity difference of two groups

Trial Locations

Locations (1)

First afflicated hospital of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China