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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020781
Receipt No. R000023983
Scientific Title The oral administration of amino acids cystine and theanine for patients with advanced EGFR mutation-positive non-small-cell lung cancer
Date of disclosure of the study information 2016/01/29
Last modified on 2019/01/30

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Basic information
Public title The oral administration of amino acids cystine and theanine for patients with advanced EGFR mutation-positive non-small-cell lung cancer
Acronym Trial of amino acids cystine and theanine
Scientific Title The oral administration of amino acids cystine and theanine for patients with advanced EGFR mutation-positive non-small-cell lung cancer
Scientific Title:Acronym Trial of amino acids cystine and theanine
Region
Japan

Condition
Condition non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate usefulness of amino acids cystine and theanine for EGFR mutation-positive non-small-cell lung cancer with afatinib
Basic objectives2 Others
Basic objectives -Others To evaluate serum glutathione in patients with afatinib and amino acids cystine and theanine
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events
Key secondary outcomes serum glutathione

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 afatinib 40mg
cystine 700mg
theanine 280mg
oral onece a day, 30days
Interventions/Control_2 afatinib 40mg
placebo
oral onece a day, 30days
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 recurrence or advanced NSCLC. (stage III or IV)
2) Afatinib have not been carried out for lung cancer.
3) Histologically confirmed EGFR mutation-positive.
4) Patient planing to receive afatinib for lung cancer.
5) 20<= years old
6) Performance Status (ECOG) 0-2
7) The functions of the main organs are maintained.
8) Patients who have estimated life expectancy longer than 90 days.
9) Submission of written informed consent concerning study participation.
Key exclusion criteria 1) Enable to oral administration
2) Ileus or intestinal obstruction
3) Constitutional diarrhea
4) Unrecovered Grade 1<= diarrhea or oral mucositis cause of previous treatment
5) Severe interstitial pneumonia
6) Uncontrollable pleural or cardiac effusion
7) Other serious complications
8) Severe allergy history
9) Receiving continuous systemic corticosteroid
10) Psychological disorder difficult to participate in this study
11) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during treatment period.
Men who will not be compliant with a contraceptive regimen during treatment period.
12) With phenylketonuria
13) Others judged by the investigator to be unsuitable for the study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Imamura
Organization Osaka International Cancer Institute
Division name Department of Thoracic Oncology
Zip code
Address 3-1-69, Otemae, Chuo--ku, Osaka
TEL 81-6-6945-1181
Email imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Madoka Kimura
Organization Osaka International Cancer Institute
Division name Department of Thoracic Oncology
Zip code
Address 3-1-69, Otemae, Chuo--ku, Osaka
TEL 81-6-6945-1181
Homepage URL
Email kimura-ma2@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization AJINOMOTO CO.,INC.
Organization
Division
Category of Funding Organization Profit organization
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 大阪国際がんセンター

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 29 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
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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
2016 Year 01 Month 28 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023983

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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