Unique ID issued by UMIN | UMIN000021202 |
---|---|
Receipt number | R000024450 |
Scientific Title | Chemotherapy using gemcitabine and docetaxel for advanced bone and soft tissue sarcoma |
Date of disclosure of the study information | 2016/02/26 |
Last modified on | 2016/02/25 17:10:31 |
Chemotherapy using gemcitabine and docetaxel for advanced bone and soft tissue sarcoma
Chemotherapy using gemcitabine and docetaxel for advanced bone and soft tissue sarcoma
Chemotherapy using gemcitabine and docetaxel for advanced bone and soft tissue sarcoma
Chemotherapy using gemcitabine and docetaxel for advanced bone and soft tissue sarcoma
Japan |
advanced bone and soft tissue tumor
Orthopedics |
Malignancy
NO
To evaluate efficacy and safety of second line chemotherapy using gemcitabine and docetaxel for advanced bone and soft tissue sarcoma.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
progression-free survival
adverse effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Gemcitabine(675mg/m2 day1,8) + Docetaxel(75mg/m2 day8)
1course/3weeks
4 courses
13 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Recurrent, metastatic or unresectable bone and soft tissue sarcoma
2)Patients who had been previously treated with first-line chemotherapy
3)ECOG Performance Status Scale(PS):0-2
4)Patients who had adequate hematologic, renal, and hepatic function
5)After obtaining informed consent
1) Past history of allegy for gemcitabine or docetaxel
2) Interstitial pneumonitis or pulmonary fibrosis
3) Active infection
4) Pregnancy
5) Lactation
6) Double cancer
10
1st name | |
Middle name | |
Last name | Hiroaki Kimura |
Nagoya City University, Graduate School of Medical Science
Department of Orthpaedic Surgery
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
052-835-8236
hiroaki030301@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hiroaki Kimura |
Nagoya City University, Graduate School of Medical Science
Department of Orthpaedic Surgery
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
052-835-8236
hiroaki030301@yahoo.co.jp
Nagoya City University, Graduate School of Medical Science
None
Self funding
NO
2016 | Year | 02 | Month | 26 | Day |
Unpublished
Open public recruiting
2014 | Year | 06 | Month | 04 | Day |
2014 | Year | 07 | Month | 29 | Day |
2016 | Year | 02 | Month | 25 | Day |
2016 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024450
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