UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015834 |
|---|---|
| Receipt number | R000018426 |
| Scientific Title | Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR Mutations |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2019/02/21 19:24:06 |
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Basic information
Public title
Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR Mutations
Acronym
Phase II Study of Afatinib in Elderly Patients
Scientific Title
Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR Mutations
Scientific Title:Acronym
Phase II Study of Afatinib in Elderly Patients
Region
| Japan |
Condition
Condition
Elderly patients with NSCLC harboring sensitive EGFR mutation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of afatinib as a first line therapy in elderly patients with NSCLC harboring sensitive EGFR mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PFS: progression free survival
Key secondary outcomes
RR: response rate
OS: overall survival
DCR: disease control rate
AE: Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Afatinib(30mg)/day p.o.
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven lung adenocarcinoma.
2) Harboring mutations of EGFR.
3) Stage III, IV
4) Chemothrapy naive patients
5) Performance Status(ECOG Scale): 0-2.
6) Adequate organ function
7) Life expectancy more than 12 weeks.
8) Written informed consent.
Key exclusion criteria
1) Interstitial pneumonia/lung fibrosis on chest CT.
2) Previous drug allergy
3) History of poorly controlled pleural effusion, pericardial effusion and ascites.
4) Active infection.
5) Current Diarrhea.
6) Ileus or intestinal tract paralysis.
7) Symptomatic brain metastasis.
8) Active concomitant malignancy.
9) History of sever heart disease.
10) History of sever psychological disease.
11) Those judged to be not suitable by the attending physician.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Kawaguchi |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
0666453793
i-gakumu@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruo Yoshimura |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
0666453793
Homepage URL
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Osaka Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪市立大学医学部附属病院（大阪府）、大阪市立総合医療センター（大阪府）、関西医大病院（大阪府）、石切生喜病院（大阪府）、淀川キリスト教病院（大阪府）、ベルランド病院（大阪府）、JR大阪鉄道病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
| 2014 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018426
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