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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022171
Receipt No. R000025545
Scientific Title Morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases: a retrospective study(WJOG4407GSS)
Date of disclosure of the study information 2016/05/02
Last modified on 2018/11/05

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Basic information
Public title Morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases: a retrospective study(WJOG4407GSS)
Acronym Morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases
Scientific Title Morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases: a retrospective study(WJOG4407GSS)
Scientific Title:Acronym Morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the predictive and prognostic value of morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases.
Basic objectives2 Others
Basic objectives -Others Predictive value of morphologic response to chemotherapy containing bevacizumab
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between morphologic response and progression-free survival
Key secondary outcomes Correlation between morphologic response and overall survival

Base
Study type Others,meta-analysis etc

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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically documented metastatic measurable adenocarcinoma of the colorectum with no prior chemotherapies for metastatic disease.The case with liver metastase
2.Age: >20, <75.
3.ECOG PS of 0 or 1.
4.Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters.
5.Written informed consent.
Key exclusion criteria 1.Brain metastasis with symptoms.
2.Massive asites, pleural effusion or pericardial effusion.
3.Double cancer with in five years prior to enroll in this study.
4.Serious non-healing wound.
5.Major surgical procedure within 28 days prior to enroll in this study.
6.Minor surgical procedure within 14 days prior to enroll in this study.
7.Other serious concomitant disease.
8.Regular use of corticosteroid.
9.Regular use of anticoagulation therapy.
10.Peripheral neuropathy > Grade 1 at baseline.
11.Active infectious disease.
12.History of serious hypersensitivity.
13.Hepatitis B surface antigen.
14.Mental disorder.
15.Pregnant or nursing.
Target sample size 70

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Ayumu Hosokawa
Organization University of Miyazaki
Division name Department of Medical Oncology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, 889-1692
TEL 0985-85-9758
Email ayhosoka@med.miyazaki-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPANJAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
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

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2016 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the predictive and prognostic value of morphologic response to chemotherapy containing bevacizumab in patients with colorectal liver metastases.

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025545

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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