UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer
Acronym	Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer
Scientific Title	Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer
Scientific Title:Acronym	Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer
Region	Japan

Condition
Condition	EGFR mutation-positive non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to prove the validity of Hange-shashin-to for diarrhea by Afatinib
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset of Grade 2 more diarrhea within 28 days by Afatinib
Key secondary outcomes

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	Hange-shashin-to
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 non-squamous cell lung cancer (2)Stage IV or recurrent NSCLC (3)Harboring sensitive EGFR mutation (4)Patients who are scheduled for administration of Afatinib (5)20 years or older (6)Performance Status (ECOG) 0-2 (7)Having adequate organ functions (8) Estimated life expectancy at least 3 months (9)With written informed consent
Key exclusion criteria	(1)Having problematic interstitial lung disease or lung fibrosis on chest CT (2)Having severe organ dysfunction (3)Having sever malabsorption syndrome or gastrointestinal dysfunction as follows, after total gastrectomy, active peptic ulcer, active inflammatory bowel disease (4)Pregnant women, or having possibility of pregnancy; man having no intent to birth control (5)In addition to the above, any contraindications to Afatinib or Hange-shashin-to (6)Having active gastrointestinal tumor (7)In addition, the primary doctor judging inappropriate for entry
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ou Yamaguchi
Organization	Saitama Medical University International Medical Center
Division name	respiratory medicine
Zip code
Address	Hidaka city, Saitama
TEL	042-984-4111
Email	ouyamaguchi@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Ou Yamaguchi
Organization	Saitama Medical University International Medical Center
Division name	respiratory medicine
Zip code
Address	respiratory medicine
TEL	042-984-4111
Homepage URL
Email	ouyamaguchi@gmail.com

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical University International Medical Center
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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 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	Completed
Date of protocol fixation	2015 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 31 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020561

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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