A Randomized, Open, Controlled, Multicenter,Phase II Clinical Trial of XELOX and XELIRI Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- XELIRI
- Conditions
- Colorectal Neoplasms
- Sponsor
- Harbin Medical University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Last Updated
- 8 years ago
Overview
Brief Summary
Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used .Objective to compare the clinical value of XELOX and XELIRI alternation regimen in the first-line treatment of advanced colorectal cancer.
Investigators
Yu Han
Chief physician
Harbin Medical University
Eligibility Criteria
Inclusion Criteria
- •Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.
- •Patients could not receive surgical resection.
- •Never received chemotherapy or radiotherapy.
- •According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- •Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score
- •The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
- •Hemoglobin(HB)≥90g/L;
- •Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
- •Blood platelet (PLT)≥80×10\^9/L; (2) Biochemical examination should comply with the following criteria:
- •Bilirubin(BIL) \<1.5 times of the upper limit of normal value (ULN)
Exclusion Criteria
- •There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- •Acute coronary artery syndrome
- •Acute heart failure (grade III or IV of NYHA classification)
- •Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).
- •(2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
- •(5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
- •There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- •ECOG score≥2
- •Abnormal coagulation function (INR\>1.5\*ULN, Activated Partial Thromboplastin Time (APTT)\>1.5\*ULN), with bleeding tendency.
- •There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
Arms & Interventions
alternative regiment
The first stage:XELOX chemotherapy and XELIRI chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage. The second stage: continue to apply another plan until there is progress or intolerance.
Intervention: XELIRI
alternative regiment
The first stage:XELOX chemotherapy and XELIRI chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage. The second stage: continue to apply another plan until there is progress or intolerance.
Intervention: XELOX
classical regiment
Use the XELOX chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI chemotherapy until there is progress or intolerance.
Intervention: XELIRI
classical regiment
Use the XELOX chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI chemotherapy until there is progress or intolerance.
Intervention: XELOX
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 22 months
Adverse events will be evaluated according to NCI CTCAE 4.0
time to failure of strategy（TFS）
Time Frame: 22 months
time from the beginning of the treatment until appear the following events, including death and implementation.the progress of disease
Secondary Outcomes
- Objective response rate (ORR)(22 months)
- Disease control rate(DCR)(22 months)
- Overall Survival (OS)(22 months)
- time to failure of strategy（TFS）(22 months)