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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010955
Receipt No. R000012819
Scientific Title Multicenter prospective observation study of salvage-line bevacizumab for unresectablemetastatic colorectal cancer in Okayama
Date of disclosure of the study information 2013/06/13
Last modified on 2018/06/25

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Basic information
Public title Multicenter prospective observation study of salvage-line bevacizumab for unresectablemetastatic colorectal cancer in Okayama
Acronym MAYUMI trial
Scientific Title Multicenter prospective observation study of salvage-line bevacizumab for unresectablemetastatic colorectal cancer in Okayama
Scientific Title:Acronym MAYUMI trial
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Observational Study of Bevacizumab with Chemotherapy for Patients Refractory or Intolerable to Oxaliplatin and Irinotecan with Unresectable/Recurrent Colorectal Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PFS; progression-free survival
Key secondary outcomes OS; overall survival
TTF; time to treatment-failure
ORR; overall response rate
Safty

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Unresectable/recurrent colorectal cancer patients, who are refractory or intolerable to oxaliplatin and irinotecan, intended to recieve any chemotherapies with bevacizumab.
2. Evaluable of the effectiveness of the treatment by image.
3. Evaluable of the safty of the treatment.
4. Be able to provide a clinical examination information.
5. Be able to do the following treatement, any chemotharapise with Bevacizumab 2.5mg/kg/week or 5.0mg/kg/week.
Key exclusion criteria None
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7257
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nagasaka
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7257
Homepage URL
Email

Sponsor
Institute Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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
2013 Year 06 Month 13 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 Completed
Date of protocol fixation
2013 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study aimed to examine the effectiveness and safety of chemotherapies with bevacizumab after the third-line treatment for unresectable advanced colon cancer.

(primary endpoint)
PFS; progression-free survival
(secondly endpoint)
OS; overall survival
TTF; time to treatment-failure
ORR; overall response rate
Safty

Management information
Registered date
2013 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012819

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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