Unique ID issued by UMIN | UMIN000026722 |
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Receipt number | R000030675 |
Scientific Title | Phase II trial of docetaxel+cisplatin+capecitabine (DCX) therapy for unresectable or recurrent HER2-negative gastric cancer |
Date of disclosure of the study information | 2017/05/01 |
Last modified on | 2023/04/01 14:46:30 |
Phase II trial of docetaxel+cisplatin+capecitabine (DCX) therapy for unresectable or recurrent HER2-negative gastric cancer
Phase II trial of docetaxel+cisplatin+capecitabine (DCX) therapy for unresectable or recurrent HER2-negative gastric cancer
Phase II trial of docetaxel+cisplatin+capecitabine (DCX) therapy for unresectable or recurrent HER2-negative gastric cancer
Phase II trial of docetaxel+cisplatin+capecitabine (DCX) therapy for unresectable or recurrent HER2-negative gastric cancer
Japan |
Gastric cancer
Gastroenterology |
Malignancy
NO
To evaluate efficacy and safety of docetaxel + cisplatin + capecitabine (DCX) for unresectable or recurrent HER2-negative gastric cancer
Efficacy
Response rate
Overall survival
Progression free survival
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Capecitabine 2000mg/m2/day days 1-14
Cisplatin 60mg/m2 day1
Docetaxel 30mg/m2 or 40mg/m2 day1
every 3 weeks
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Gastric adenocarcinoma. HER2 IHC- or IHC1+, or IHC2+/FISH-
2) Stage IV
3) ECOG PS 0-1
4) No previous chemothrapy or radiation therapy
5) Laboratory data
1.WBC>=3,000/mimcrol
2.Neutrophil>=1,500/microl
3.Hemoglobin>=8.0 g/dL
4.Platelet>=100,000/microl
5.Total bilirubin<=1.5 mg/dL
6.AST(GOT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
7.ALT(GPT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
8.Serum creatinine<=1.3 mg/dL
9.Creatinine clearance>=60 mL/min
10.Ejection fraction on echo cardiogram>=50%
1) HER2 IHC 3+, or IHC 2 and FISH+
2) Uncontrolled diabetes
3) Uncontrolled hypertension
4) Unstable angina pectoris, or a history of myocardial infarction within six months
5) Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema
6) Synchronous cancers (except for cases whose prognositc facter is gastric cancer)
7) Systemic infection requiring treatment
8) Fever above 38 degree Celsius
9) A possibility of pregnancy or during pregnancy, or lactating women
10) Psychosis or psychotic symptoms
11) Continuous systemic administration of steroids (oral or intravenous)
35
1st name | |
Middle name | |
Last name | Osamu Maeda |
Nagoya University Hospital
Department of Clinical Oncology and Chemotherapy
65 Tsurumai-cho Showa-ku Nagoya
052-741-2111
maeda-o@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Osamu Maeda |
Nagoya University Hospital
Department of Clinical Oncology and Chemotherapy
65 Tsurumai-cho Showa-ku Nagoya
052-741-2111
maeda-o@med.nagoya-u.ac.jp
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Nagoya University
Other
NO
2017 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 05 | Month | 01 | Day |
2017 | Year | 05 | Month | 26 | Day |
2017 | Year | 05 | Month | 26 | Day |
2024 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 27 | Day |
2023 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030675
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