Back to results

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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Capecitabine Oral Tablet [Xeloda]

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

First afflicated hospital of zhejiang university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2 week group

3 week group

Arm Description

Outcomes

Primary Outcome Measures

DFS

disease free survival

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

toxicity difference of two groups

Full Information

NCT ID

NCT03564912

First Posted

May 27, 2018

Last Updated

August 24, 2021

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03564912

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 12, 2018 (Actual)

Primary Completion Date

August 24, 2021 (Actual)

Study Completion Date

August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2 week group

Arm Type

Experimental

Arm Title

3 week group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Capecitabine Oral Tablet [Xeloda]

Other Intervention Name(s)

oxaliplatin

Intervention Description

2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w

Primary Outcome Measure Information:

Title

DFS

Description

disease free survival

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

toxicity difference of two groups

Time Frame

2 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

First afflicated hospital of zhejiang university

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs