Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01679327|
Recruitment Status : Unknown
Verified September 2012 by yihebali chi, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : September 6, 2012
Last Update Posted : September 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Oxaliplatin Drug: Xeloda Drug: Calcium folinate (CF) Drug: 5-FU Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)
Other Name: EloxatinDrug: Xeloda
Other Name: CapetabineDrug: Calcium folinate (CF)
Other Name: Calcium folinateDrug: 5-FU Drug: Bevacizumab
Other Name: Avastin
- Overall response rate [ Time Frame: 36 months ]During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.
- progression free survival [ Time Frame: 36 months ]The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.
- overall survival [ Time Frame: 36 months ]From the time patients receive the first cycle chemotherapy to the time they die for any reason.
- Number of Participants with Adverse Events [ Time Frame: 36 months ]Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679327
|Cancer Institute&Hospital Chinese Academy of Medical Sciences||Recruiting|
|Contact: Yihebali Chi, MD 8610-87788145 Yihebalichi@yahoo.com|
|Principal Investigator:||Yihebali Chi, Doctor||Chinese academy of medical science|
|Study Director:||Jinwan WANG||Chinese academy of medical science|