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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015035
Receipt No. R000017496
Scientific 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
Date of disclosure of the study information 2014/09/03
Last modified on 2016/11/09

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Basic information
Public 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
Acronym 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
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Itaru Endo
Organization Yokohama City University Hospital
Division name gastroenterological surgery
Zip code
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
1st name
Middle name
Last name Kazuhisa Takeda
Organization Yokohama City University Hospital
Division name gastroenterological surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2014 Year 04 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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