UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009742 |
|---|---|
| Receipt number | 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 16:12:26 |
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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
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
Sponsor or person
Institute
Fukuoka University School of Medicine Department of Gastroenterological Surgery
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011414
