Unique ID issued by UMIN | UMIN000002510 |
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Receipt number | R000003059 |
Scientific Title | phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2 |
Date of disclosure of the study information | 2009/09/16 |
Last modified on | 2012/04/09 13:28:56 |
phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2
phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2
phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2
phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2
Japan |
non-squamous,non-small cell lung cancer
Pneumology |
Malignancy
NO
to evaluate efficacy and safety of pemetrexed in the first line treatment of advanced non-small cell lung cancer with PS2
Safety
Phase II
Response rate
Progression-free survival,Overall survival,QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
pemetrexed
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)patients with stage IIIB or stage IV, who is impossible of radical irradiation
3)Non prior chemotherapy and irradiation for any other carcinomas.But we can permit picibani and minocycline for a pleurodesis.
4)With measurable lesion
5)20 years or older
6)ECOG PS 2
7)Adequate organ function
8)Life expectancy more than 12 weeks
9)Written informed consent
1)Interstitial pneumonia or pulmonary fibrosis detectable on Xray
2)History of severe drug allergy
3)History of poorly controlled pleural effusion,pericardial effusion and ascites.When that is controlled,we can permit.
4)History of symptomatic brain metastases
5)Hystory of active double cancer
6)History of severe comorbidity disease
i)uncontrollable angina pectoris,herat failure)
ii)active infection
7)History of active psychological disease
8)Pregnancy,breast feeding or wish of
future bearing
9)with systemic continuous steroid therapy
10)Other conditions not suitable for this
study
31
1st name | |
Middle name | |
Last name | Young Hak Kim |
Graduate School of Medicine, Kyoto University
Department of Respiratory Medicine
54 Shogoin-Kawaharacho, Sakyo-Ku, Kyoto 606-8507, Japan
1st name | |
Middle name | |
Last name | yuichi sakamori |
Graduate School of Medicine, Kyoto University
Department of Respiratory Medicine
54 Shogoin-Kawaharacho, Sakyo-Ku, Kyoto 606-8507, Japan
075-751-3830
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government
NO
京都大学医学部付属病院
2009 | Year | 09 | Month | 16 | Day |
Unpublished
Open public recruiting
2009 | Year | 09 | Month | 16 | Day |
2009 | Year | 12 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2009 | Year | 09 | Month | 16 | Day |
2012 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003059
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