Unique ID issued by UMIN | UMIN000014752 |
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Receipt number | R000017026 |
Scientific Title | Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer |
Date of disclosure of the study information | 2014/08/04 |
Last modified on | 2017/10/14 19:35:05 |
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected 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 adjuvant therapy, which is administered orally alternate day for 1 year for patients with curatively resected pancreatic cancer or biliary tract cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Treatment completed rate
Overall survival
Relapse-free survival
Adverse events
Time to treatment failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily every monday, wednesday,friday and sunday for 1 year.
20 | years-old | <= |
Not applicable |
Male and Female
<pancreatic cancer>
1)pancreatic cancer which is curatively resected(R0 or R1)
2)patients without Stage IVb pancreatic cancer
<biliary tract cancer>
1)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which is curatively resected(R0 or R1)
2)patients without Stage Ia nor Stage IVb biliary tract cancer
<pancreatic cancer and biliary tract cancer>
3)with no distant metastasis, cancerous ascites
4)age: >=20
5)No postoperative complications and possible to start treatment within 12 weeks from operation
6)sufficient function of important organs
WBC: >=2,000/mm3 and <=12,000/mm3
Neut:>=1,500/mm3
Platelet: >=75,000/mm3
Hem: >=8.0g/dl
sT.bil: <=3.0mg/dl
AST, ALT: <= 150IU/L
Ccr: >=30 ml/min/body
7) oral intake
8)written informed consent
*ECOG P.S.:anything is OK
1) administration contraindication of TS-1
2)with recurrence before the entry of this study
3)with clinically important infection
4)with sever heart failure
5)with interstitial pneumonia or pulmonary fibrosis
6)with sever complication(Intestinal paralysis, Ileus, uncontrollable diabetes mellitus, Renal failure, Liver failure etc)
7)massive ascites fluid or pleural effusion
8)repetitive blood infusion for gastrointestinal hemorrhage or blood infusion within 14 days before accrual
9)with mental disorder receving treatment or needing treatment
10)has active carcinoma except carcinoma in situ
11) administered Flucytosine, Phenytoin, Warfarin potassium
12)pregnant women or lactating women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant
13) doctor's decision not to be registered to this study
75
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)、川崎市立井田病院(神奈川県)
2014 | Year | 08 | Month | 04 | Day |
Unpublished
Completed
2013 | Year | 07 | Month | 18 | Day |
2013 | Year | 07 | Month | 18 | Day |
2015 | Year | 12 | Month | 31 | Day |
2014 | Year | 08 | Month | 03 | Day |
2017 | Year | 10 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017026
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