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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine Oral Tablet [Xeloda]

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • First afflicated hospital of zhejiang university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2 week group	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; Other Names: oxaliplatin
ACTIVE_COMPARATOR: 3 week group	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; Other Names: oxaliplatin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2018
• Primary Completion (ACTUAL): August 24, 2021
• Study Completion (ACTUAL): August 24, 2021

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: ZhejiangU020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes