Unique ID issued by UMIN | UMIN000002524 |
---|---|
Receipt number | R000003083 |
Scientific Title | A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination |
Date of disclosure of the study information | 2010/01/01 |
Last modified on | 2010/09/24 12:45:29 |
A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination
A Phase I study of intraperitoneal Docetaxcel with S-1 and Cisplatin for gastric cancer with peritoneal dissemination (KUGC05)
A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination
A Phase I study of intraperitoneal Docetaxcel with S-1 and Cisplatin for gastric cancer with peritoneal dissemination (KUGC05)
Japan |
gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To assess the safety and to determine the recommended dose of intraperitoneal docetaxel plus systemic S-1 and cisplatin for gastric cancer with peritoneal dissemination
Safety
To determine the maximum tolerated dose and the recommended dose
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Chemotherapy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histological diagnosis of gastric adenocarcinoma
2) Laparoscopy revealed macro- or microscopic peritoneal dissemination as the only factor for Stage IV
3) Distant metastasis was excluded by image diagnosis
4) No prior therapy for gastric cancer
5) Performance Status (ECOG):0-1
6) Oral intake of S-1 is possible
7) Written informed consent
8) Biology and biochemistry within normal limits
1)Active bleeding from the tumor
2)Paralysis of intestine or ileus
3)Diarrhea(watery stool)
4)Synchronous multicancer
5)Pleural effusion or ascites requiring control
6)Serious comorbidity including
-Serious infection
-Uncontrollable diabetes mellitus
-Heart failure requireing control
-Uncontrolled arrhythmia or angina
-Severe phyciatric disease
-Interstitial pneumonitis or fibroid lung
7)Myocardial infarction within 6 months
8)Patient who has experienced serious allergy for any drug or polysorbate 80 in the past
9)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study
10)Patient who requires continuous use of flucytosine
11)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
15
1st name | |
Middle name | |
Last name | Yoshiharu Sakai |
Graduate School of Medicine, Kyoto University
Department of Surgery
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
1st name | |
Middle name | |
Last name | Hiroshi Okabe |
Graduate School of Medicine, Kyoto University
Department of Surgery
hokabe@kuhp.kyoto-u.ac.jp
Department of Surgery
Graduate School of Medicine, Kyoto University
Department of Surgery
Graduate School of Medicine, Kyoto University
Self funding
NO
2010 | Year | 01 | Month | 01 | Day |
Unpublished
Terminated
2009 | Year | 09 | Month | 01 | Day |
2011 | Year | 01 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2009 | Year | 09 | Month | 18 | Day |
2010 | Year | 09 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003083
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |