UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020781 |
|---|---|
| Receipt number | 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 16:06:10 |
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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
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
kimura-ma2@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023983
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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