UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002560
Receipt No. R000002974
Scientific Title Mechanism and prediction of bevacizumab-induced hypertension and proteinuria
Date of disclosure of the study information 2009/10/01
Last modified on 2018/10/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Mechanism and prediction of bevacizumab-induced hypertension and proteinuria
Acronym Study of bevazizumab-induced hypertension and proteinuria
Scientific Title Mechanism and prediction of bevacizumab-induced hypertension and proteinuria
Scientific Title:Acronym Study of bevazizumab-induced hypertension and proteinuria
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To observe hypertension and proteinuria after bevacizumab administration. And to investigate the serum level of angiogenic factors predict the onset of hypertension and proteinuria.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To identify whether the biomarkers in blood or urine predict bevacizumab associated hypertension and proteinuria.
Key secondary outcomes

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
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) Histologically confirmed adenocarcinoma of colon or rectum.
2) Unresectable locally advanced or metastatic disease.
3) Age is over 20 years.
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
5) Patinets with or without measurable or evaluable lesion are eligible.
6) Without history of bevacizumab chemotherapy, without more than 2 chemotherapys, no chemotherapy 4 weeks prior to bevacizumab treatment. History of adjuvant chemotherapy administrated bofore 6 months exclude from prior chemotherapy.
7) Adequate organ function, evidenced by following laboratory results within 14 days prior to randamization.
Leukocyte count<12,000cells/mm3
Absolute neutrophil count<2,000/mm3
Hemoglobin<9.0g/dl
Platelet count<100,000/mm3
Total bilirubin<1.5mg/dl
AST and ALT<2.5 times the upper limit of normal(ULN)
Creatinine<1.5mg/dl
Urine protein/urine creatinine ratio<1.0
8)Signed, written informed concent is obtained.
Key exclusion criteria 1) Current severe infeciton, or suspicious of severe infection with fever greater than 38 degrees centigrade.
2) Sensory neuropathy.
3) Uncontrollable diabetes
4) Uncontrollable hypertension
5) Severe abnormality in electrocardiogram, or cardiovascular disease (e.g., heart failure, angina) with clinical symptom
6) Severe pulmonary disease (e.g., interstitial pneumonia, pulmonary fibrosis, severe pumonary emphysema)
7) Severe systemic disease(e.g., ileus, renal failure, hepatic failure)
8) Clinical or radiographic evidence of brain metastases
9) History of thromboembolism(e.g, myocardial infarction, cerebral infarction, deep venous thromboembolism, pulmonary thrmboembolism)
10) Uncontrollable gastrointestinal ulcer
11) Carcinomatous peritonitis controlled with drainage
12) Any surgery within 4weeks prior to randamization(the exception of implanted port system)
13) Clinical evidence or potential of dysfunction of coagulation
14) Current daily treatment with warfarin
15) Active synchronous cancer
16) Current known infection with HBV or HCV
17) Pregnant or lactating women, or men and women without wanting pregnancy
18) Severe psychiatric disorder
19) Current daily treatment with corticosteroid
20) Severe hypersensitivity to medicine(hypersensitivity to platinum, fluorouracil or 5-HT3 receptor antagonist is ineligible)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasutsuna Sasaki
Organization Saitama medical university
Division name Department of medical oncology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshikado Kaneta
Organization Saitama medical university
Division name Department of medical oncology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL
Homepage URL
Email

Sponsor
Institute Saitama medical university
Institute
Department

Funding Source
Organization Saitama medical university
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
2009 Year 10 Month 01 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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 29 Day
Last modified on
2018 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.