Unique ID issued by UMIN | UMIN000014805 |
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Receipt number | R000017079 |
Scientific Title | Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer |
Date of disclosure of the study information | 2014/08/11 |
Last modified on | 2017/08/30 22:40:39 |
Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer
Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer
Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer
Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer
Japan |
pancreatic cancer or biliary tract cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
The objective is to evaluate the feasibility of TS-1 which is administered orally alternate day for 6 weeks for patients with unresectable pancreatic cancer or biliary tract cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Treatment completed rate
Overall survival
Progeression-free survival
Adverse events
Time to treatment failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily every monday, wednesday,friday and sunday for 6 weeks.
Not applicable |
Not applicable |
Male and Female
1)unresectable or recurrent pancreatic cancer or biliary tract cancer(include locally advanced or recurence)
2)standard chemotyerapy cannot be performed for some reason
3)sufficient function of important organs
WBC: >=2,000/mm3 and <=12,000/mm3
Neut:>=1,000/mm3
Platelet: >=75,000/mm3
Hem: >=8.0g/dl
sT.bil: <=3.0mg/dl
AST, ALT: <= 150IU/L
Ccr: >=30 ml/min/body
4)oral intake
5)written informed consent
*ECOG P.S.:anything is OK
1)administration contraindication of TS-1
2)with clinically important infection
3)with sever heart failure
4)with interstitial pneumonia or pulmonary fibrosis
5)with sever complication(Intestinal paralysis, Ileus, uncontrollable diabetes mellitus, Renal failure, Liver failure etc)
6)massive ascites fluid or pleural effusion
7)repetitive blood infusion for gastrointestinal hemorrhage
8)with mental disorder receving treatment or needing treatment
9)administered Flucytosine, Phenytoin, Warfarin potassium
10)pregnant women or lactating women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant
11)doctor's decision not to be registered to this study
100
1st name | |
Middle name | |
Last name | Osamu Itano |
Department of Surgery, Keio University School of Medicine
Department of Surgery
Shinanomachi 35, Shinjuku-ku, Tokyo
03-3353-1211
contact@keio-hpbts.jp
1st name | |
Middle name | |
Last name | Minoru Kitago |
Department of Surgery, Keio University School of Medicine
Department of Surgery
Shinanomachi 35, Shinjuku-ku, Tokyo
03-3353-1211
contact@keio-hpbts.jp
Keio University School of Medicine
none
Self funding
NO
慶応義塾大学病院(東京都)、国家公務員共済組合連合会立川病院(東京都)
2014 | Year | 08 | Month | 11 | Day |
Unpublished
Terminated
2013 | Year | 11 | Month | 06 | Day |
2013 | Year | 11 | Month | 06 | Day |
2014 | Year | 08 | Month | 09 | Day |
2017 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017079
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