Unique ID issued by UMIN | UMIN000005583 |
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Receipt number | R000006602 |
Scientific Title | Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer |
Date of disclosure of the study information | 2011/05/11 |
Last modified on | 2013/05/10 17:17:03 |
Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer
Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer
Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer
Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer
Japan |
Non-small-cell lung cancer
Pneumology |
Malignancy
YES
To evaluate the efficacy and safety of the combination of Carboplatin and Pemetrexed with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy.
Safety,Efficacy
Phase II
Response rate
Overall survival
Safety
Progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin+Pemetrexed
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.Histologically confirmed Stage 3B/4 non-small-cell lung cancer and non-squamous cell carcinoma.
2.No prior chemotherapy.
3.With one or more measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver1.1
4.Age 20<=, <=75
5.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
6.Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function.
7.A life expectancy of more than 3 months.
8.All patients provided written informed consent before initiation of study-related procedures.
1.Symptomatic Brain metastasis.
2.History of active double cancer.
3.Severe infection
4.Severe comorbidity (heart failure tendency to hemorrhages, uncontrollable hypertension, uncontrollable diabetes, etc)
5.Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
6.With a history of drug sensitivity.
7.Pregnant or lactating women or those who declined contraception.
8.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
35
1st name | |
Middle name | |
Last name | Kiyoshi Mori |
Tochigi Cancer Center
Division of Thoracic Oncology
4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834
028-658-5151
1st name | |
Middle name | |
Last name | Takashi Kasai |
Tochigi Cancer Center
Division of Thoracic Oncology
takasai@tcc.pref.tochigi.lg.jp
Tochigi Cancer Center
None
Self funding
NO
2011 | Year | 05 | Month | 11 | Day |
Unpublished
Completed
2009 | Year | 11 | Month | 11 | Day |
2009 | Year | 11 | Month | 01 | Day |
2011 | Year | 05 | Month | 10 | Day |
2013 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006602
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