Unique ID issued by UMIN | UMIN000011930 |
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Receipt number | R000013650 |
Scientific Title | Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer. |
Date of disclosure of the study information | 2013/11/01 |
Last modified on | 2013/10/01 16:20:18 |
Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer.
SISCO-GC 01
Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer.
SISCO-GC 01
Japan |
Gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the feasibility of adjuvant S-1 chemotherapy in alderly patients with stageII/III gastric cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Feasibility (Treatment completion rate)
OS, RFS, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
To find out the safety and efficacy of the anti-cancer drug for elderly patients with gastric cancer
75 | years-old | <= |
Not applicable |
Male and Female
1)Histopathologically confirmed gastric cancer.
2)Curability A (R0).
3)Stage II (excluded T3N0) / III (Japanese classification).
4)No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis.
5)age:75.
6)No previous treatment(radiation therapy, chemotherapy, hormone therapy) for cancer except for the initial gastric resection for the primary lesion.
7)Oral administration is possible within 12 weeks after gastric resection.
8)Without any other severe diseases and adequate organ functions.
Leu: >=4,000 /mm3, <=ULN
Plt: >= 100,000 /mm3
T-bil: <= 1.5 g/dL
ALT<=ULNx2.5
AST<=ULNx2.5
Ccr: >= 30 mg/min
9)With written informed consent.
1)Active double cancer and/or past history of other cancer.
2)Flucytosin, phenytoin, or warfarin potassium administration.
3)Allergic more than and equal to grade3.
4)Patients with significant complications.
5)History of serious allergic reaction with S-1.
6)Men who have willing to become partner's pregnant.
7)Patients with HIV,HBV.
8)Not appropriate for the study at the physician's assessment.
65
1st name | |
Middle name | |
Last name | Masahide Ikeguchi |
Tottori University
Divsion of Surgical Oncology
36-1 nishi-cho, Yonago, 683-8504, Japan
0859-38-6567
masaike@med.tottori-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroaki Saito |
Tottori University
Divsion of Surgical Oncology
36-1 nishi-cho, Yonago, 683-8504, Japan
0859-38-6567
sai10@med.tottori-u.ac.jp
Tottori University, Divsion of Surgical Oncology
non
Other
NO
鳥取市立病院(鳥取県)、鳥取生協病院(鳥取県)、西伯病院(鳥取県)、島根大学医学部附属病院(島根県)、
公立八鹿病院(兵庫県)、鳥取大学医学部附属病院(鳥取県)、鳥取県立中央病院(鳥取県)、島根県立中央病院(島根県)、鳥取赤十字病院(鳥取県)、松江赤十字病院(島根県)、山陰労災病院(鳥取県)、米子医療センター(鳥取県)、鳥取県立厚生病院(鳥取県)、浜田医療センター(島根県)、益田地域医療センター医師会病院(島根県)、益田赤十字病院(島根県)、松江生協病院(島根県)、松江市立病院(島根県)、日野病院(鳥取県)、済生会江津総合病院(島根県)、公立雲南総合病院(島根県)、出雲市立総合医療センター島根県)、医療法人十字会野島病院(鳥取県)、医療法人同愛会博愛病院(鳥取県)
2013 | Year | 11 | Month | 01 | Day |
Unpublished
Open public recruiting
2010 | Year | 04 | Month | 09 | Day |
2010 | Year | 08 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013650
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