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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009742
Receipt No. R000011414
Scientific Title A validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone. (AVOID)
Date of disclosure of the study information 2013/01/10
Last modified on 2019/05/23

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Basic information
Public title A validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone. (AVOID)
Acronym A validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone. (AVOID)
Scientific Title A validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone. (AVOID)
Scientific Title:Acronym A validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone. (AVOID)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the preventive effect of dexamethasone against oxaliplatin-induced hypersensitivity reactions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Hypersensitivity reaction incidence
Key secondary outcomes Safety
Relative dose intensity
Response rate
Progression free survival

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 Dexamethasone 13.2mg/body i.v.(day1)
Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2,p.o.(day1-14)
to be repeated every 3 weeks
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 colorectal cancer
2. Treatment plan of XELOX(+-bevacizumab) for colorectal cancer
3.No prior chemotherapy for colorectal cancer
4.Performance Status: 0-1 (ECOG criteria)
5.Age: 20 years old or older
6.Signed written informed consent
7.Vital organ functions are preserved within 14 days prior to entry
Neutrophil:>=1,000/mm3
Platelet:>=75,000/mm3
Hb.:>= 8.0 mg/dl
T.bil.:<= 2.0 mg/dl
Creatinin:<=1.35mg/dl(female),1.80mg/dl(male)
Key exclusion criteria 1.Prior severe drug allerg
2.Presence of active infection
3.Multiple malignancy within 5 years disease free interval
4.Uncontrolled hypertension or diabetes
5. Severe peripheral nerve disorder
6.Chronic systemic treatment of corticosteroid
7.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy
8.Inadequate for study enrollment by the physician
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
TEL
Homepage URL
Email

Sponsor
Institute Fukuoka University School of Medicine Department of Gastroenterological Surgery
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 福岡大学病院(福岡県)
福岡山王病院(福岡県) 
関西医科大学病院(大阪府) 
藤田保健衛生大学病院(愛知県)
金沢医科大学(石川県)
新潟がんセンター(新潟県)
佐野病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 10 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 Main results already published
Date of protocol fixation
2012 Year 11 Month 12 Day
Date of IRB
2012 Year 12 Month 15 Day
Anticipated trial start date
2013 Year 01 Month 10 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 10 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011414

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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