UMIN-CTR Clinical Trial

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
Last 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
1st 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