UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab
Title of the study (Brief title)	Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate efficacy and safety of XELOX+bevacizumab therapy as first-line chemotherapy in clinical practice for patients with advanced or metastatic colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Frequency and Degree of Hand-foot symdrome(HFS),Neuropathy and Vascular disorders
Key secondary outcomes	Time To Failure, Disease Free Survival, Overall Survival, Overall Response Rate, Frequency and Degree of Adverse Events Except HFS,Neuropathy and Vascular disorders. Resection Rate of Liver Metastases, Rate of R0 Resection of Liver Metastases

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1)Capecitabine at a dose of 2,000mg/m2/day orally in 2 divided doses for 2weeks on and 1week rest 2) tri-Weekly oxaliplatin at a dose of 130mg/m2 intravenously 3) tri-weekly bevacizumab at a dose of 5mg/kg intravenously
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. 20 years or older 2.Histologically confirmed colorectal cancer 3.With target lesion by RECIST ver.1.1 4.Unrecetable recurrent or metastatic colorectal cancer.Not be administered any therapies except radio therapy when primary disease or primary recurrence and not be administered any therapy for reccurent tumor 5.Patients who can take food orally 6. Patients who will be administered the therapy of XELOX+Bevacizumab 7.Written IC
Key exclusion criteria	1. Prior or synchronous invasive malignancy unless disease free for a minimum of 5 years 2.Previous history of severe drug-induced allergy caused by capecitabine 3.Be Administered or less than 7 days finished administration Compound Drug of tegafur,gimeracil and oteracil potassium 4.Severe kidney trouble 5.Previous history of severe drug-induced allergy caused by oxaliplatin 6. Neuropathy or sensory dysfunction 7.Previous history of severe drug-induced allergy caused by bevacizumab 8.Pregnant women who are capable of pregnancy or intend to get pregnant 9.Patients judged inappropriate for this study by the physicians
Target sample size	38

Research contact person
Name of lead principal investigator	Mikinori Sato
Organization	Gamagori City Hospital
Division name	Surgery
Address	1-1, Mukaida, Hiratacho, Gamagori-city, Aichi-pref. Japan
TEL	0533-66-2295
Email	sato-mikinori@gamahp.jp

Public contact
Name of contact person	Mikinori Sato, Masayasu Hara
Organization	Nagoya City University
Division name	Gastrointestinal Surgery
Address	1, Kawasumi, Mizuhocho, Mizuho-ku, Nagoya-city,Aichi-pref. Japan
TEL	052-853-8226
Homepage URL
Email	mshara@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Gastrointestinal Surgery
Institute
Department

Funding Source
Organization	Nagoya City University Gastrointestinal Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 10 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 01 Month 18 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005716