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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025748
Receipt No. R000029219
Scientific Title A phase II study of a short bevacizumab infusion in patients with metastatic colorectal cancer.
Date of disclosure of the study information 2017/04/03
Last modified on 2017/03/27

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Basic information
Public title A phase II study of a short bevacizumab infusion in patients with metastatic colorectal cancer.
Acronym A phase II study of a short bevacizumab infusion
Scientific Title A phase II study of a short bevacizumab infusion in patients with metastatic colorectal cancer.
Scientific Title:Acronym A phase II study of a short bevacizumab infusion
Region
Japan

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

Objectives
Narrative objectives1 We investigated the safety and efficacy of short bevacizumab infusion in patients with metastatic colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
The rate of infusion reaction
Key secondary outcomes The rate of infusion reaction
The rate of bevacizumab-induced proteinuria and hypertension

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bevacizumab was given over 30 min at the first time. If patients had no infusion reaction,the time was shortend to 10 min
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) Patients with histologically verified adenocarcinoma of the colon and rectum
2) Patients with Unresectable metastatic/recurrent colorectal cancer
3) Patents without a previous chemotherapy or radiation therapy
4) ECOG Performance status of 0-2
Key exclusion criteria 1) Serious complication (interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, poorly-controlled diabetes, poorly-controlled hypertension)
2) Symptomatic or asymptomatic but treated heart disease
3) Active infection.
4) History of serious drug hypersensitivity or a history of drug allergy
5) Brain metastasis
6) Patients with perforated disease
7) Patients with thrombosis
8) Hemorrhagic diathesis, coagulation disorder
9) Pregnant or lactating woman
10) Not appropriate for the study at the physician's assessment



Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Taira
Organization Osaka City University Graduate School of Medicine
Division name Dept of Gastroenterology
Zip code
Address Asahimachi 1-4-3 Abeno-ku, Osaka
TEL 06-6645-3811
Email koichit@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Taira
Organization Osaka City University Graduate School of Medicine
Division name Dept of Gastroenterology
Zip code
Address Asahimachi 1-4-3 Abeno-ku, Osaka
TEL 06-6645-3811
Homepage URL
Email koichit@med.osaka-cu.ac.jp

Sponsor
Institute Dept of Gastroenterology Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Dept of Gastroenterology Osaka City University Graduate School of Medicine
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
2017 Year 04 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 19 Day
Last modified on
2017 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029219

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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