Unique ID issued by UMIN | UMIN000000484 |
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Receipt number | R000000581 |
Scientific Title | Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer |
Date of disclosure of the study information | 2006/09/11 |
Last modified on | 2016/06/26 23:23:15 |
Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Japan |
untreated advanced or recurrent gastric cancer
Gastroenterology | Hematology and clinical oncology |
Malignancy
NO
The aim of this study is to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of S-1, cisplatin and docetaxelin patients with advanced gastric cancer, and to evaluate efficacy and safety of this combination therapy
Safety,Efficacy
Exploratory
Phase I,II
Phase I: Maximum Tolerated Dose, Recommended dose
Phase II: Response rate
Toxicity, Progression free survival, Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Cisplatin, Day1
Level 0: 30mg/m2
Level 1: 40mg/m2
Level 2: 50mg/m2
Level 3: 60mg/m2
S-1 (80mg/m2), Day1-14, 22-35
Docetaxel (40mg/m2), Day22
Repeat every 6 weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Histologically or cytologically confirmed adenocarcinoma of the stomach
2) Unresectable disease
3) Sufficient oral intake
4) Measurable lesion(s) defined by RECIST
5) No prior chemotherapy, radiotherapy for advanced cancer
6) Age of 20-74 years
7) ECOG performance status of 0 to 2
8) Expected survival more than 3 months
9) Adequate organ function
10) Written informed consent
1) Active other malignancy
2) Interstitial pneumonitis, pulmonary fibrosis
3) Massive pleural effusion or massive ascites
4) Active infection
5) Watery diarrhea
6) Other uncontrolled severe illness
7) Brain metastases
8) Pregnant or lactating women
9) Not appropriate for the study at the physician's assessment
40
1st name | |
Middle name | |
Last name | Toshiro Sugiyama |
University of Toyama
Department of Gastroenterology and Hematology, Faculty of Medicine
2630 Sugitani, Toyama, 930-0194, Japan
076-434-7301
tsugi@med.u-toyama.ac.jp
1st name | |
Middle name | |
Last name | Ayumu Hosokawa |
University of Toyama
Department of Gastroenterology and Hematology, Faculty of Medicine
2630 Sugitani, Toyama, 930-0194, Japan
076-434-7301
ayhosoka@med.u-toyama.ac.jp
Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
Self funding
NO
2006 | Year | 09 | Month | 11 | Day |
Partially published
Completed
2006 | Year | 07 | Month | 25 | Day |
2006 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2006 | Year | 09 | Month | 11 | Day |
2016 | Year | 06 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000581
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