Unique ID issued by UMIN | UMIN000010280 |
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Receipt number | 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 16:15:26 |
A Self-controlled Trial of Prophylactic
Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
A Self-controlled Trial of Prophylactic
Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Japan |
Colorectal Cancer
Gastroenterology | Dermatology | Adult |
Malignancy
NO
To evaluate the efficacy of prophylactic topical application of vitamin K1 cream for cetuximab-related skin rash
Efficacy
Confirmatory
Explanatory
Phase III
The incidence of grade2-5 rash acneiform (CTCAE v4.0) of face whithin 4 weeks from starting cetuximab containing chemotherapy
-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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Other |
Vitamin K1 cream
Plcebo cream
20 | years-old | <= |
Not applicable |
Male and Female
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
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
33
1st name | |
Middle name | |
Last name | Yoshio Kiyohara |
Shizuoka Cancer Center
Dermatology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
055-989-5222
y.kiyohara@scchr.jp
1st name | |
Middle name | |
Last name | Kentaro Yamazaki |
Shizuoka Cancer Center
Gastrointestinal Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
055-989-5222
k.yamazaki@scchr.jp
Shizuoka Industrial Foundation Pharma Valley Center
Bristol-Myers Squibb
Profit organization
Japan
NO
静岡県立総合病院
2013 | Year | 03 | Month | 25 | Day |
Unpublished
No longer recruiting
2013 | Year | 01 | Month | 21 | Day |
2013 | Year | 03 | Month | 25 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 05 | Month | 31 | Day |
2014 | Year | 05 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2013 | Year | 03 | Month | 19 | Day |
2015 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012034
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