Unique ID issued by UMIN | UMIN000004230 |
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Receipt number | R000005085 |
Scientific Title | Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2014/04/24 11:53:53 |
Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients
Japan |
Thymic carcinoma
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of nedaplatin plus gemcitabine in previously treated advanced thymic carcinoma patients.
Safety,Efficacy
Response rate
Overall survival, progression-free survival, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
administration of nedaplatin and gemcitabine
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Historogically or cytologically confirmed thymic carcinoma.
2)Unresectable disease or recurrent disease after surgery.
3)One or more prior chemotherapy or chemoradiotherapy.
4)Measurable by RECIST criteria.
5)ECOG Performance status of 0-2.
6)Sufficient organ functions.
1.WBC >= 4000/mm3
2.neutrophil >= 2000/mm3
3.Hb >= 9.0g/dL
4.Plt >= 100000/mm3
5.T-bil < 1.5mg/dL
6.AST, ALT < 100IU/L
7.Cr < 1.5mg/dL
8.PaO2 >= 60Torr or SpO2 >= 90%
7)Expected to live over 3 months
8)Written informed consent.
1)Symptomatic brain metastasis
2)Poorly controlled pleural or pericardial effusion.
3)Need for thoracic radiation.
4)History of double cancer within 5 years.
5)Serious complications.
1.Uncontrollable heart disease (heart failure, ischemic heart disease).
2.History of myocardial infarction within 6 months.
3.Interstitial pneumonia or pulmonary fibrosis detectable on chest X ray.
4.Uncontrollable diabetes mellitus.
5.Uncontrollable hypertension.
6.Active infection.
6)History of severe allergy.
7)Previous administration of nedaplatin or gemcitabine.
8)Now pregnant or lactation.
9)Judged to be not suitable by the attending physician.
25
1st name | |
Middle name | |
Last name | Shintaro Kanda |
Shinshu University School of Medicine
First Department of Internal Medicine
3-1-1 Asahi, Matsumoto, Japan
0263-37-2631
shintarokanda@gmail.com
1st name | |
Middle name | |
Last name | Shintaro Kanda |
Shinshu University School of Medicine
First Department of Internal Medicine
3-1-1 Asahi, Matsumoto, Japan
0263-37-2631
shintarokanda@gmail.com
First Department of Internal Medicine, Shinshu University School of Medicine
Shinshu University Hospital
Self funding
NO
2010 | Year | 10 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 09 | Month | 06 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 17 | Day |
2014 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005085
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