UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy
Acronym	Bi-weekly XELOX with Bevacizumab
Scientific Title	A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy
Scientific Title:Acronym	Bi-weekly XELOX with Bevacizumab
Region	Japan

Condition
Condition	advanced and/or recurrent colorectal cancer
Classification by specialty	Medicine in general Gastroenterology Surgery in general
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of bi-weekly XELIRI plus bevacizumab in advanced colorectal cancer as first-line chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	overall survival Time to Treatment Failur Response Rate Disease Control Rate Relative Dose Intensity Rate of Adverse Event safety

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	XELIRI plus bevacizumab therapy /Capecitabine;2,000 mg/m2 day1-8(orally, day1 after dinner; day8 after breakfast) /Oxaliplatin 85 mg/m2 day1 /Bevacizumab: 5mg/kg day 1 The treatment is repeated every two weeks until disease progression or severe toxicity
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) Written informed consent after the explanation of the content of the examination (2) Age of 20 years or older (3) ECOG PS 0-1 (4) Life expectancy more than 3 months (5) Histopathologically confirmed colorectal cancer (6) Measurable or evaluable disease (RECIST ver.1.1) (7) Metastatic colorectal cancer which has non prior therapy (8)Adequate organ functions
Key exclusion criteria	(1) Severe renal function disorder (2) History of serious drug hypersensitivity or a history of drug allergy (3) History of active double cancer within 5 years (4) Active infections (5) Distinctly abnormal ECG or cardiovascular disease (6) Cpmplication of thromboembolism,severe pulmonary disease(interstitial pneumonia, pulmonary fibrosis, mild Emphysema) "(7) complication of GI perforation or hemorrhage ,Paresis of intestine or intestinal obstruction " (8) Massive pleural effusion or ascites that required drainage (9) Brain metastasis (10) Complication of mental disorder,CNS disease, cerebrovascular disease. (11) Uncontrollable hypertension or diabetes mellitus (12) Uncontrollable diarrhea "(13) Patients with non-healing wounds,or surgery (thoracotomy, laparotomy) within 4 weeks " (14) Non-healing fracture (15) Bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day) (16) Pregnant or lactating woman (17) Peripheral neuropathy (18) Other conditions not suitable for this study
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Shoichi Middle name Last name Hazama
Organization	Yamaguchi University Graduate School of Medicibe
Division name	Digestive surgery and surgical oncology
Zip code	755-8505
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL	+81-836-22-2264
Email	hazama@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Shoichi Middle name Last name Hazama
Organization	Yamaguchi University Graduate School of Medicibe
Division name	Digestive surgery and surgical oncology
Zip code	755-8505
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL	+81-836-22-2264
Homepage URL
Email	hazama@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicibe, Digestive surgery and surgical oncology
Institute
Department

Funding Source
Organization	Yamaguchi University Graduate School of Medicibe, Digestive surgery and surgical oncology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yamaguchi University
Address	1-1-1 Minami-Kogushi
Tel	0836222428
Email	me223@yamaguchi-u.ac.jp

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	2013 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 17 Day
Date of IRB	2012 Year 12 Month 25 Day
Anticipated trial start date	2013 Year 03 Month 18 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 03 Month 17 Day
Last modified on	2022 Year 03 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012008