UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031117 |
|---|---|
| Receipt number | R000035538 |
| Scientific Title | Multicenter, prospective interventional study to evaluate therapeutic effect of Afatinib in patients with advanced non-small cell lung cancer, EGFR mutation positive and brain metastasis |
| Date of disclosure of the study information | 2018/02/03 |
| Last modified on | 2023/02/07 21:57:06 |
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Basic information
Public title
Multicenter, prospective interventional study to evaluate therapeutic effect of Afatinib in patients with advanced non-small cell lung cancer, EGFR mutation positive and brain metastasis
Acronym
Afatinib MET-PET/CT study
Scientific Title
Multicenter, prospective interventional study to evaluate therapeutic effect of Afatinib in patients with advanced non-small cell lung cancer, EGFR mutation positive and brain metastasis
Scientific Title:Acronym
Afatinib MET-PET/CT study
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate therapeutic effect of Afatinib using RECIST and MET-PET/CT in patients with advanced non-small cell lung cancer, EGFR mutation positive and brain metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate amino acid metabolic reactions obtained by followings
To evaluate MET-PET/CT at baseline (SUVmax,L/N ratio)
To evaluate MET-PET/CT at 4 and 8 weeks after start of therapy (SUVmax,L/N ratio)
Key secondary outcomes
To evaluate relationship between amino acid metabolic reactions and following points
PFS
OS
Response rate
TTF
Disease control rate
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 | Device,equipment |
Interventions/Control_1
Treatment of afatinib
Evaluation using MET-PET/CT
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 or cytologically confirmed diagnosis of non-squamous cell and non-small cell lung cancer
2)Stage IV advanced unresectable, postoperative recurrent cancer
3)To detect following mutations by analysis of tissue or cell sample
4)Deletion in exon19 or L858R point mutation in exon 21 of EGFR gene
5)Brain metastasis verified by MRI or CT and >= 10 mm measurably
6)Using afatinib as first line treatment.
7)Age >= 20 years at obtained informed consent
8)ECOG performance status 0-2
9)The function of organs (marrow,liver,kidney,etc.)is maintained enough
10)Life expectancy >= 3 months
Key exclusion criteria
1)Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug pneumonia, etc. are complicated
2)Active other malignancy
3)Adjuvant chemotherapy
4)Infection to need to treat with antibiotics or antifungal agent via intravenous administration
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hanaoka |
Organization
Shinshu University
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
Shinshu University, 3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
TEL
+81-263-37-2631
masayuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazunari |
| Middle name | |
| Last name | Tateishi |
Organization
Shinshu University
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
Shinshu University, 3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
TEL
+81-263-37-2631
Homepage URL
tateishi@shinshu-u.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
Tel
+81-263-37-2572
mdrinri@shinshu-u.ac.jp
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
信州大学医学部附属病院（長野県）、慈泉会相澤病院（長野県）、長野赤十字病院（長野県）、長野市民病院（長野県）、諏訪赤十字病院（長野県）、篠ノ井総合病院（長野県）、信州上田医療センター（長野県）、まつもと医療センター中信松本病院（長野県）、伊那中央病院（長野県）、飯田市立病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/re/reports/detail/11971
Publication of results
Partially published
Result
URL related to results and publications
https://jrct.niph.go.jp/re/reports/detail/11971
Number of participants that the trial has enrolled
1
Results
In one enrolled case, treatment with Afatinib reduced the SUVmax and LNRmax rates of brain metastases.
Results date posted
| 2022 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
One case was enrolled during the study period.
68-year-old female, T2bN3M1c, stage IV unresectable advanced non-small cell lung cancer. EGFR Ex.19 positive, performance status 0, no previous treatment history. The evaluation lesions were the left cerebellar lesion for brain metastasis, the left lower lobe mass and the right anterior lymph node for other than brain metastasis.
Participant flow
Of the 6 facilities, no cases were registered from 5 facilities except Shinshu University Hospital. It is considered that the number of registered cases cannot be expected to increase due to the extension of the study period, so the study period was not extended. The planned observation period was achieved for one registered case.
Adverse events
No adverse events other than those known were caused by the drugs used.
Outcome measures
At baseline, it was SUVmax 4.71 and LNRmax 2.12. It was SUVmax 3.21 LNRmax 1.13 after 4 weeks and SUVmax 3.34 LNRmax 1.08 after 8 weeks. Progression-free survival was 12 months, maximum therapeutic effect was partial response, survival time and response rate, and disease control rate were not determined.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035538
