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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010280
Receipt No. R000012034
Scientific Title A Self-controlled Trial of Prophylactic Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Date of disclosure of the study information 2013/03/25
Last modified on 2015/03/19

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Basic information
Public title A Self-controlled Trial of Prophylactic
Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Acronym Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Scientific Title A Self-controlled Trial of Prophylactic
Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Scientific Title:Acronym Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Dermatology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of prophylactic topical application of vitamin K1 cream for cetuximab-related skin rash
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes The incidence of grade2-5 rash acneiform (CTCAE v4.0) of face whithin 4 weeks from starting cetuximab containing chemotherapy
Key secondary outcomes -The safety of vitamin K1 cream
-The incidence of grade2-3 rash acneiform (MASCC scale) of face whithin 4 weeks from starting cetuximab containing chemotherapy
-The compliance of prophylactic treatment of vitamin K1 cream

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Vitamin K1 cream
Interventions/Control_2 Plcebo cream
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 comfirmed colorectal
adenocarcinoma
2. Plannning to administer cetuximab
containing chemotherapy
3. ECOG Performance Status(PS):0-2
4. Age >=20
5. Life expectation >=4wks
6.Written informed concent
Key exclusion criteria 1. Grade1-3 cutaneous symptom of face
2. Continuous administration of steroid or
antibiotics for whole-body or face
3. Administration of vitamin K or vitamin
K antagonist
4. History of cetuximab containing
chemotherapy
5. Physician's decision
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kiyohara
Organization Shizuoka Cancer Center
Division name Dermatology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Email y.kiyohara@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Yamazaki
Organization Shizuoka Cancer Center
Division name Gastrointestinal Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Homepage URL
Email k.yamazaki@scchr.jp

Sponsor
Institute Shizuoka Industrial Foundation Pharma Valley Center
Institute
Department

Funding Source
Organization Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 静岡県立総合病院

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 25 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 No longer recruiting
Date of protocol fixation
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 25 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2014 Year 05 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 19 Day
Last modified on
2015 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012034

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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