UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the relationship of image on the morphological changes and prognosis by XELOX + bevacizumab therapy in the healing unresectable advanced or recurrent colorectal cancer with liver metastasis
Title of the study (Brief title)	Examination of the relationship of image on the morphological changes and prognosis by XELOX + bevacizumab therapy in the healing unresectable advanced or recurrent colorectal cancer with liver metastasis
Region	Japan

Condition
Condition	colon cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will compare prospectively the correlation of RECIST and prognosis and the correlation of XELOX + bevacizumab morphological changes of liver metastatic sites from CT image.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	OS
Key secondary outcomes	PFS,ORR,Safety

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Patients with XELOX + bevacizumab therapy plan It is a colon cancer (2) histologically has been confirmed I have one or more measurable liver metastatic lesions (3) major axis more than 1cm From adjuvant chemotherapy end however (which is a healing unresectable colorectal cancer progression of recurrence (4) initial drug therapy Recurrence have passed more than six months is regarded as the first drug therapy) Is 20 years of age or older age (5) obtaining informed consent at the time Is 0 ~ 1 (6)The Eastern Cooperative Oncology Group is (ECOG) Performance Status (7) This test content, written consent of the person has been obtained
Key exclusion criteria	(1) On the image, brain metastases are found, or from clinical symptoms, brain metastasis is suspected. (2) Cerebrovascular neuropathy, or with a history within one year prior to enrollment. It has been conducted surgery within 4 weeks. (3)Prior to enrollment, biopsy with incision, the suture treatment for trauma, or have implemented fine-needle aspiration cytology within 1 week. (4) Traumatic fracture not healing (5) Bleeding tendency, or to have a coagulopathy. (6)The administration of an anti-thrombotic agent for thrombosis within 10 days before registration (7) Require the administration of aspirin formulation of 325 mg or more. (8) It has with symptoms at the time of registration and the (corresponding to grade 2 or more in Ver.3.0 Japanese translation JCOG / JSCO version NCI-CTCAE) heart disease or are doing some kind of treatment. Alternatively, there is a history of myocardial infarction within one year prior to enrollment. (9) on the image, a body cavity fluid requiring treatment. (10)Digestive cancer carcinoma in situ of the cervix and skin basal cell carcinoma, or by endoscopic mucosal resection endoscopic, healing has been confirmed, transition is not observed overlap cancer of less than five years was (healing disease-free interval it has to a) except for the prostate cancer (11) And has a neuropathy of grade 1 or more Ver.3.0 Japanese translation JCOG / JSCO version NCI-CTCAE (12)Pregnant women, lactating women, pregnancy test positive. Or, patients with no intention to contraception. (13) Oxaliplatin, or with a history of hypersensitivity to severe capecitabine (14) Suspected (DPD) deficiency dihydropyrimidine dehydrogenase, adverse reactions to fluoropyrimidine drugs was expressed. (15)Investigator deems inappropriate to participate in the test (16)The cases with serious complications (uncontrolled digestive ulcer, hypertension, diarrhea, infections, gastrointestinal perforation, such as interstitial pneumonia or pulmonary fibrosis)
Target sample size	50

Research contact person
Name of lead principal investigator	Itaru Endo
Organization	Yokohama City University Hospital
Division name	gastroenterological surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2800
Email	endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Kazuhisa Takeda
Organization	Yokohama City University Hospital
Division name	gastroenterological surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2800
Homepage URL
Email	kazutake@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	none
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	横浜市立大学附属市民総合医療センター（神奈川県） 横浜市立大学附属病院（神奈川県） 横須賀共済病院（神奈川県） 横浜市立市民病院（神奈川県） 藤沢市民病院（神奈川県） 済生会横浜市南部病院（神奈川県） 独立行政法人国立病院機構横浜医療センター（神奈川県） 横浜みなと赤十字病院（神奈川県） 横浜保土ヶ谷中央病院（神奈川県） 横須賀市立市民病院（神奈川県） 伊東市民病院（神奈川県） NTT東日本関東病院（神奈川県） 済生会若草病院（神奈川県） 横浜掖済会病院（神奈川県） 長津田厚生総合病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 04 Month 10 Day
Anticipated trial start date	2014 Year 09 Month 04 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	Unpublished
URL releasing results
Results
Other related information	XELOX + bevacizumab therapy is performed until PD Bevacizumab 7.5mg / kg Oxaliplatin 130mg / m2 Capecitabine 2,000mg / m2 / day

Management information
Registered date	2014 Year 09 Month 03 Day
Last modified on	2016 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017496