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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564912
• Other study ID #: ZhejiangU020
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 12, 2018
• Est. completion date: August 24, 2021

Study information

• Verified date: August 2021
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine 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

Locations

Country	Name	City	State
China	First afflicated hospital of zhejiang university	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	disease free survival	through study completion, an average of 1 year
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	toxicity difference of two groups	2 weeks