Unique ID issued by UMIN | UMIN000008604 |
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Receipt number | R000010116 |
Scientific Title | A Randomized Phase II Study of Dose Schedule of TS-1 for Metastatic/Advanced Pancreatic Cancer |
Date of disclosure of the study information | 2012/08/02 |
Last modified on | 2015/09/02 16:56:55 |
A Randomized Phase II Study of Dose Schedule of TS-1 for Metastatic/Advanced Pancreatic Cancer
Study of Alternate-day dosing for Pancreatic Cancer (PAN-01)
A Randomized Phase II Study of Dose Schedule of TS-1 for Metastatic/Advanced Pancreatic Cancer
Study of Alternate-day dosing for Pancreatic Cancer (PAN-01)
Japan |
Metastatic/Locally Advanced Pancreatic Cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
Evaluation of Alternate-day Administration schedule of TS-1 compared with Practical schedule.
Efficacy
Exploratory
Pragmatic
Phase II
Overall Survival
QOL(EQ-5D,EORTC-C30), progression-free survival, PFS, time to treatment failure, TTF,response rate, RR, Adverse Event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
Practical use(4wks daily and 2wks rest)
Alternate-day
20 | years-old | <= |
80 | years-old | > |
Male and Female
(1) Invasive pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or adenosquamous carcinoma.
(2) Locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer. Having of measurable lesions must not be required.
(3) Patients with no previous treatment (radiotherapy, chemotherapy, immunotherapy, etc.) for pancreatic cancer, except resection.
(4) Patients must be >=20 years old and <80 years old at the time of consent.
(5) ECOG Performance Status must be 0 or 1.
(6) The following criteria must be satisfied.
1)White blood cell count >=3,500 /mm3
2)Neutrophil count >=2,000 /mm3
3)Hemoglobin >= 9.0 g/dL
4)Platelet count >=100,000 /mm3
5)Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
6)AST <=150 IU/L ,ALT <=150 IU/L
7)Serum Creatinine <=1.2 mg/dL
8)Creatinine Clearance >= 50 mL/min
(7) Oral intake is possible.
(8) Clinically normal ECG within 28 days before registration.
(9) Patient must have signed the consent form.
(1) Interstitial pneumonia or pulmonary fibrosis.
(2) Watery diarrhea.
(3) Severe infections (without viral hepatitis) or being suspected (fever evaluation >=38 degrees).
(4) Serious complication (heart failure, renal disorder, liver disorder, bleeding digestive ulcer, intestinal tract paralysis, and etc. ).
(5) Moderate or greater pleural effusion, ascites fluid (requiring drainage).
(6) Cerebral metastasis.
(7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 year) except carcinoma in situ or intramucosal cancer.
(8) Patients who require administration of flucytosine, phenytoin, and warfarin.
(9) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period.
(10) Serious mental disorder.
(11) Drug hypersensitivity.
(12) Patients who are judged by doctors inappropriate to perform the study safely.
190
1st name | |
Middle name | |
Last name | Hiroki Yamaue |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera, Wakayama,Japan
073-477-2300
trial2nd@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Shimizu |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera, Wakayama,Japan
073-477-2300
http://www.csp.or.jp/cspor/
trial2nd@wakayama-med.ac.jp
Wakayama Medical University
Public Health Research Foundation
Non profit foundation
Japan
Public Health Research Foundation/Taiho Pharmaceutical Co.,LTD.
Taiho Pharmaceutical Co.,LTD.
NO
和歌山県立医科大学 第二外科
和歌山県立医科大学 消化器内科
2012 | Year | 08 | Month | 02 | Day |
Unpublished
No longer recruiting
2012 | Year | 07 | Month | 23 | Day |
2012 | Year | 08 | Month | 03 | Day |
2015 | Year | 07 | Month | 31 | Day |
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 10 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2012 | Year | 08 | Month | 02 | Day |
2015 | Year | 09 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010116
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