Unique ID issued by UMIN | UMIN000004866 |
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Receipt number | R000005793 |
Scientific Title | Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer |
Date of disclosure of the study information | 2011/01/14 |
Last modified on | 2019/01/21 18:23:12 |
Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Feasibility study of Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Carboplatin plus Pemetrexed in patients with recurrent and postoperative non-small cell lung cancer
Japan |
non small and non squamous lung cancer
Pneumology | Chest surgery |
Malignancy
NO
feasibility study
Safety
Exploratory
Pragmatic
Phase I,II
feasibility study (4 courses)
1-year recurrence-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Pemetrexed, Carboplatin
20 | years-old | <= |
Not applicable |
Male and Female
1.Initial chemottherapy
2.ECOG performance status0-1
3.Stage IIor III after complete resection
4.Age of 20 years or older
5.Laboratory parameters obtained before registation
WBC count:>4000/uL, <12000/uL
neutrophil count:>2000/uL
Platelet count:>10*10000/uL
Hemoglobin:>9.5g/dL
GOT,GPT:<100 IU/L
Total bilirubin:<2.0mg/dL
PaO2:>60 torr
creatinine:<1.5mg/dL
6.Anticipated life expectancy of at least 3 months
7.Capable to registrate in 30days after surgery
8.Capable to stay in the hospital
9.Obtained informed consent
1.Interstitial pneumonia or pulmonary fibrosis on Chest Xray
2.Unstable pleural effusion formation
3.Superior vena cava syndrome
4.Uncotrolled diabetes mellitus, hypertension, liver dysfunction, angina pectoris, and acute myocardial infarction
5.Severe infection, a sign of severe infection
6.Grade2 or worse peripheral nerve disorder at the time of enrollment
7.Regular user of NSAIDs
8.Pregnant woman, lactating woman, woman of child-bearing potential, woman who wish to pregnancy
9.Severe drug allergy
10.Severe complication
11Other inadequate reasons
12.New lesion that is recognized before enrollment
30
1st name | |
Middle name | |
Last name | Mitsuaki Sakai |
University of Tsukuba
Department of Thoracic Surgery
1-1-1 Tennoudai, Tsukuba, Japan
029-853-3097
misakai@md.tsukuba.ac.jp
1st name | |
Middle name | |
Last name | Mitsuaki Sakai |
University of Tsukuba
Department of Thoracic Surgery
1-1-1Tennoudai, Tsukuba, Japan
029-853-3097
http://www.md.tsukuba.ac.jp/
misakai@md.tsukuba.ac.jp
Department of Thoracic Surgery,
University of Tsukuba
Department of Thoracic Surgery,
University of Tsukuba
Self funding
Japan
NO
2011 | Year | 01 | Month | 14 | Day |
Partially published
http://jlcs55.umin.jp/program.html
No longer recruiting
2009 | Year | 11 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2015 | Year | 06 | Month | 30 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 03 | Month | 31 | Day |
2011 | Year | 01 | Month | 13 | Day |
2019 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005793
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