Unique ID issued by UMIN | UMIN000003372 |
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Receipt number | R000004098 |
Scientific Title | Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer |
Date of disclosure of the study information | 2010/04/01 |
Last modified on | 2013/03/02 13:49:47 |
Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
NO
For patients with hematological or non-hematological grade 2>= adverse events in clinical stage II/III advanced gastric cancer with adjuvant TS-1
, study possibility of adverse events reduction or therapy continuity by PSK, and verify whether this regimen is useful or not as phase III protocol regimen.
Safety,Efficacy
Exploratory
Phase II
grade 2>= adverse events rate after starting protocol therapy (TS-1 + PSK combination therapy)
(number of adverse event cases/number of enrolled cases)
TS-1 compliance
(number of therapy completion courses/number of therapeutic plan courses)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TS-1:80-120mg/day
2 times/day, p.o., day1-28.
One course takes 42 days.
For one year from surgery.
PSK:3g/day
3 times/day(1g/time), p.o., daily.
For one year including TS-1 holidays.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histological proven gastric cancer
2) Stage II (except for T1) or stage III
3) Onset of hematological or non-hematological grade 2>= adverse events within 1-3 course of TS-1
4) No liver metastasis, peritoneal metastasis or distant metastasis and peritoneal washing cytology negative
5) Age 20-80 years
6) No history of pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery
7) Written informed consent.
1) Schronous, mtaschronous double cancer/ multiple cancer
2) administration contraindication of TS-1 (refer package insert)
3) Regular use of flucytosine, phenytoin or warfarin potassium
4) History of severe drug allergy (grade 3>=)
5) Severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure etc.
6) Severe watery diarrhea
7) Pregnancy or lactation
8) Male intension that get with child
9) HIV positive
10) Patients who are recognized as inadequate patients by doctors whit responsibility in this study.
31
1st name | |
Middle name | |
Last name | Inoue Kentaro |
Kansai Medical University
Department of Surgery
2-3-1 Shin-machi, Hirakata-city, Osaka
072-804-0100
1st name | |
Middle name | |
Last name |
Kansai Medical University
Department of surgery
072-804-0101
inoueke@hirakata.kmu.ac.jp
Kansai Medical University
Department of Surgery, Kansai Medical University
Self funding
Japan
none
NO
関西医科大学附属枚方病院
2010 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2010 | Year | 03 | Month | 25 | Day |
2010 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2010 | Year | 03 | Month | 24 | Day |
2013 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004098
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