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 |
Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study-
Effectiveness and feasibility of afatinibe in postoperative recurrent EGFR mutated lung cancer
Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study-
Effectiveness and feasibility of afatinibe in postoperative recurrent EGFR mutated lung cancer
Japan |
EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Chest surgery |
Malignancy
YES
To investigate effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Efficacy
Phase II
Progression free survival
Over all survival
Response rate
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients treated with afatinib 40mg per day until disease progression and/or intolerable toxic effect.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
38
1st name | Kimihiro |
Middle name | |
Last name | Shimizu |
Gunma University Graduate School of Medicine
General surgical science
3718511
3-39-15 Showa-machi, maebashi city
0272208245
kmshimizu@gmail.com
1st name | Kai |
Middle name | |
Last name | Obayashi |
Gunma University Graduate School of Medicine
General surgical science
3718511
3-39-15 Showa-machi, maebashi city
0272208245
tnagashima82@gmail.com
Gunma university
General surgical science
Self funding
Gunma university clinical trial department
3-39-15 Showa-machi, maebashi city
0272208240
mkunimine@gunma-u.ac.jp
NO
2014 | Year | 12 | Month | 01 | Day |
Unpublished
Preinitiation
2014 | Year | 06 | Month | 25 | Day |
2014 | Year | 07 | Month | 10 | Day |
2019 | Year | 06 | Month | 30 | Day |
2014 | Year | 07 | Month | 01 | Day |
2020 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016803