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JAPANESE
国立保健医療科学院
UMIN ID: UMIN000003961

Registered date:28/07/2010

XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced and recurrent colorectal cancer
Date of first enrollment2010/07/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1000mg/m2 of oral Xeloda twice daily on days 1 through 14 every 3 weeks. L-OHP 130mg/m2 is administered intravenous injection on day 1. (Bevacizumab 7.5mg/kg is administered intravenous injection on day 1.)

Outcome(s)

Primary OutcomeFOLFOX(+bevacizumab) from PFS
Secondary Outcomesafety,cycle number of XELOX,Quolity of life(FACT-C)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1)Pathologically proved colorectal cancer 2)Age at registration is above 20 3)ECOG Performance status is 0 or 1 4)FOLFOX in treatment(or at least SD)but problems such as continuous infusion of impossible to continue treating patients, Identified as difficult cases at the request of the patient continuous infusion 5)Intake of normal diet and oral drugs is possible 6)With advanced or recurrent measurable disease,colon or rectal cancer 7)At least two cycles or XELOX(+bevacizumab)treatment for possible 8)Written informed consent is taken
Exclude criteria1)severe renal failure 2)severe hypersensitivity to have a history fluorouracil,lebohorinatokarushiumu, platinum, bevacizumab 3)activity with multiple cancers(After which no more than five years of activity) 4)brain metastases(only when using bevacizumab) 5)FOLFOX(+bevacizumab)treatment for 3 or more months after 6)In addition, if deemed unsuitable to participate in this study is the responsible physician

Related Information

Contact

public contact
Name Akihito Tsuji
Address Japan
Telephone
E-mail
Affiliation Kochi Health Sciences Center Department of Medical Oncology
scientific contact
Name Akihito Tsuji
Address 2125-1 Ike, Kochi-city,Kochi,Japan Japan
Telephone
E-mail
Affiliation Kochi Health Sciences Center Department of Medical Oncology