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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017750 |
Receipt No. | R000020561 |
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 |
Date of disclosure of the study information | 2015/06/01 |
Last modified on | 2017/07/31 |
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 |
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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 |
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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 |
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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 |
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Region |
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Condition | ||||
Condition | EGFR mutation-positive non-small cell lung cancer | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama Medical University International Medical Center | ||||||
Division name | respiratory medicine | ||||||
Zip code | |||||||
Address | Hidaka city, Saitama | ||||||
TEL | 042-984-4111 | ||||||
ouyamaguchi@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Saitama Medical University International Medical Center | ||||||
Division name | respiratory medicine | ||||||
Zip code | |||||||
Address | respiratory medicine | ||||||
TEL | 042-984-4111 | ||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |