Unique ID issued by UMIN | UMIN000003933 |
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Receipt number | R000004728 |
Scientific Title | Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma |
Date of disclosure of the study information | 2010/08/01 |
Last modified on | 2023/06/06 10:41:56 |
Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma
Amrubicin and cisplatin for invasive thymoma
Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma
Amrubicin and cisplatin for invasive thymoma
Japan |
thymoma
Medicine in general | Pneumology | Hematology and clinical oncology |
Malignancy
NO
To assess the efficacy and safety of amrubicin plus cisplatin for invasive thymoma.
Efficacy
Exploratory
Pragmatic
Phase II
Objective response rate
Overall survival, safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
amrubicin and cisplatin
20 | years-old | <= |
Not applicable |
Male and Female
Histologically confirmation of invasive recurrent or metastatic thymoma
Tumor has measureble lesion as per
RECIST (v1.1).
ECOG PS 0-1
Adult patient(>20 year of age)
No previous chemotherapy and immunotherapy was received
At least 4 weeks since prior surgery or radiation therapy.
Adequate organ function.
White blood cell count >= 4000/mm3
Absolute neutrophil count (ANC)>= 2000/mm3
and platelet count>= 100,000/mm3
Hemoglobin >= 10 gm/Dl
Total bilirubin <= 1.5mg/dl
AST, ALT must be <= 100IU/L
Creatinine <= 1.5 mg/d
PaO2 :>=60Torr
Thymoma associated paraneoplastic syndrome was clinically controlled.
Other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
pregnant, or lactating women
active bacterial infection
Severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months.
Uncontorllable diabetes mellitus or hypertension or glaucoma.
Interstitial lung diesease
Active ulcer disease
Continuers corticosteroids therapy.
Uncontrolled Psychiatric problem which decrease treatment
40
1st name | |
Middle name | |
Last name | Keita Kudo |
National Hospital Organization Osaka Minami Medical Center
Department of respiratory medicine
2-1, Kidohigashimachi, Kawachi-Nagano-City
0721-53-5761
keita.k@ommc-hp.jp
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
WJOG datacenter
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2010 | Year | 08 | Month | 01 | Day |
Partially published
Completed
2010 | Year | 07 | Month | 17 | Day |
2010 | Year | 09 | Month | 06 | Day |
2010 | Year | 08 | Month | 01 | Day |
2016 | Year | 11 | Month | 17 | Day |
2010 | Year | 07 | Month | 21 | Day |
2023 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004728
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