UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014443 |
|---|---|
| Receipt number | R000016803 |
| Scientific Title | Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study- |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2020/07/05 11:17:34 |
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Basic information
Public title
Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study-
Acronym
Effectiveness and feasibility of afatinibe in postoperative recurrent EGFR mutated lung cancer
Scientific Title
Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study-
Scientific Title:Acronym
Effectiveness and feasibility of afatinibe in postoperative recurrent EGFR mutated lung cancer
Region
| Japan |
Condition
Condition
EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Over all survival
Response rate
Safety
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 |
Interventions/Control_1
Patients treated with afatinib 40mg per day until disease progression and/or intolerable toxic effect.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Eligible patients had pathologically confirmed NSCLC and non-squamous carcinoma according to American Joint Committee on Cancer criteria.
2)Postoperative recurrent patient and no adaptation of surgery or radiotherapy for recurrent site.
3)Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST)
4)Tumour tissue had to be EGFR mutation-positive at the screening,including common (Leu858Arg, exon 19 deletions)
5)Chemotherapy native patients
6)An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7)Patient have adequate organ function
Key exclusion criteria
Patients were excluded
1)if they had interstitial pneumonia, pneumoconiosis, Radiation pneumonitis, drug-induced pneumonia.
2)Patient had already received EGFR-TKI
3)Patient had uncontrollable pleural effusion, ascites, pericardial effusion 4)Patient had uncontrolled concomitant diseases, baseline organ function.
5)Patients suspected of being pregnant or lactating women
6)Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment)
7)Patients had additional significant malignancies diagnosed within the past 5 years
8)Tumour tissue had to T790M EGFR mutation
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Kimihiro |
| Middle name | |
| Last name | Shimizu |
Organization
Gunma University Graduate School of Medicine
Division name
General surgical science
Zip code
3718511
Address
3-39-15 Showa-machi, maebashi city
TEL
0272208245
kmshimizu@gmail.com
Public contact
Name of contact person
| 1st name | Kai |
| Middle name | |
| Last name | Obayashi |
Organization
Gunma University Graduate School of Medicine
Division name
General surgical science
Zip code
3718511
Address
3-39-15 Showa-machi, maebashi city
TEL
0272208245
Homepage URL
tnagashima82@gmail.com
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
Funding Source
Organization
General surgical science
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
Gunma university clinical trial department
Address
3-39-15 Showa-machi, maebashi city
Tel
0272208240
mkunimine@gunma-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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016803
