UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022171 |
|---|---|
| Receipt number | 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 | 2023/01/10 09:49:38 |
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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
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
ayhosoka@med.miyazaki-u.ac.jp
Public contact
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 28 | Day |
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
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025545
