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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024113
Receipt No. R000027754
Scientific Title A phase III, open-label, randomized trial evaluating topical corticosteroid therapy for the facial acneiform dermatitis by EGFR Inhibitors: Stepwise rank down from potent corticosteroid.
Date of disclosure of the study information 2016/10/03
Last modified on 2019/03/25

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Basic information
Public title A phase III, open-label, randomized trial evaluating topical corticosteroid therapy for the facial acneiform dermatitis by EGFR Inhibitors: Stepwise rank down from potent corticosteroid.
Acronym A comparative study for Facial Acneiform dermatitis by EGFR Inhibitors by Stepwise rank down of corticoSteroid (FAEISS study)
Scientific Title A phase III, open-label, randomized trial evaluating topical corticosteroid therapy for the facial acneiform dermatitis by EGFR Inhibitors: Stepwise rank down from potent corticosteroid.
Scientific Title:Acronym A comparative study for Facial Acneiform dermatitis by EGFR Inhibitors by Stepwise rank down of corticoSteroid (FAEISS study)
Region
Japan

Condition
Condition Lung cancer
Colorectal cancer
Classification by specialty
Gastroenterology Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is designed to evaluate the effects of pre-emptive topical corticosteroid therapies with serially ranking down from very strong levels compared with that with serially ranking up from weak levels for the acneiform dermatitis by EGFR inhibitors in patients with lung or colorectal cancer without history of anti-EGFR therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of more than grade 2 (moderate) facial acneiform dermatitis during the 10-week skin treatment period (by central review).
Key secondary outcomes ・ Proportion of more than grade 2 (moderate) facial acneiform dermatitis (by central review)
・ Proportion of more than grade 3 (severe) facial acneiform dermatitis (by central review)
・ Proportion of switching EGFR therapies due to facial acneiform dermatitis
・ Proportion of continuing EGFR therapy at the end of protocol treatment
・ Proportion of more than grade 1 (mild) facial acneiform dermatitis at the end of protocol treatment (by central review)
・ Incidence of adverse events on the face (by central review).
・ Proportion of non-worsening in QOL scores

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A pre-emptive therapy with daily 100mg (200mg in some institution) of minocycline hydrochloride, topical heparinoid moisturizer (two times a day) and EGFR inhibitors are followed with weak topical 0.05% prednisolone cream (two times a day) after development of the acneiform dermatitis. According to exacerbation of the dermatitis, topical corticosteroids will be serially ranking up from weak level.
Interventions/Control_2 A pre-emptive therapy with daily 100mg (200mg in some institution) of minocycline hydrochloride and topical heparinoid moisturizer (two times a day) are started with EGFR inhibitors. After development of the acneiform dermatitis, topical corticosteroid therapy is started with very strong class will be ranking down to strong, medium, mild and weak every two weeks for 10 weeks.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Eligible patients have following (1) or (2). (1) patient with non-small cell lung cancer with mutated EGFR, and is planned to treat with erlotinib or afatinib. (2) patient with colorectal cancer with wild type KRAS and NRAS, and is planned to treat with cetuximab or panitumumab.
2)Histopathologically the samples from surgery or biopsy specimen was diagnosed following (1)or (2). (1) Non-small cell lung cancer (SCC, adenocarcinoma, large cell cancer {except large cell endocrine cancer}, adenosquamous cell cancer, unclassified cancer), (2) Colorectal adenocarcinoma (including mucinous adenocarcinoma and signet ring cell carcinoma) by the 8th edition as the JSCCR guidelines for the treatment of colorectal cancer.
3) Unresectable or relapse after curative resection
4) 20 years old and more, and 79 years old and younger.
5) An Eastern Cooperative Oncology Group performance status of 0 or 1
6) No bacterial, fungal, syphilis, and viral infection of the face.
7) No history of EGFR inhibitor therapy (history of therapy with cytotoxic drugs is acceptable).
8) Absence of esophageal stenosis or obstruction
9) Written informed consent.
Key exclusion criteria 1) Current topical corticosteroid therapy for facial lesion of atopic dermatitis and other skin diseases.
2) Presence of the metastatic skin lesions of lung or colorectal cancer.
3) Presence of the skin lesions including burn, frost bite, trauma or scar that influence to evaluation of the facial lesions.
4) Administration of following drugs: warfarin, sulphonylurea, digoxin, oral contraceptives, vitamin A analog, retinoid, steroid
5) History of allergy or serious side effects by minocycline hydrochloride
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name yoshio Kiyohara
Organization Shizuoka Cancer Center
Division name Department of 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 Naoya Yamazaki
Organization National Cancer Center Hospital
Division name Department of Dermatologic Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3547-5201
Homepage URL
Email nyamazak@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 静岡県立静岡がんセンター(静岡県)
国立がん研究センター中央病院(東京都)
愛知県がんセンター中央病院(愛知県)
大阪府立成人病センター(大阪府)
新潟県立がんセンター新潟病院(新潟県)
東北大学病院(宮城県)
国立がん研究センター東病院(千葉県)
三重大学病院(三重県)
四国がんセンター(愛媛県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 03 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
2016 Year 08 Month 10 Day
Date of IRB
2016 Year 07 Month 27 Day
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
2019 Year 04 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 20 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027754

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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