UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015035 |
|---|---|
| Receipt number | 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 14:37:15 |
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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
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
kazutake@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017496
