UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024113 |
|---|---|
| Receipt number | 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 | 2020/09/23 09:44:43 |
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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 | yoshio |
| Middle name | |
| Last name | Kiyohara |
Organization
Shizuoka Cancer Center
Division name
Department of Dermatology
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
y.kiyohara@scchr.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Yamazaki |
Organization
National Cancer Center Hospital
Division name
Department of Dermatologic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3547-5201
Homepage URL
nyamazak@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
National Cancer Center Ethics Committee
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3547-5201
irst@ml.res.ncc.go.jp
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
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027754
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