Unique ID issued by UMIN | UMIN000003751 |
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Receipt number | R000004546 |
Scientific Title | A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery. |
Date of disclosure of the study information | 2010/06/30 |
Last modified on | 2010/06/14 19:13:09 |
A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and safety of Gemcitabine Hydrochloride and Krestin combination therapy in stage III or IVa pancreatic cancer after surgery as a feasibility trial.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Disease-free survival
1) Overall survival
2) Incidence of adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gemcitabine Hydrochloride
1000 mg/m2 as Gemcitabine by drip infusion for 30 minutes
Once a week for 3 weeks
One course takes 4 weeks
Maximum 6 courses
Krestin
3 g per day
3 times per day
Daily oral administration
Start at initial administration of Gemcitabine Hydrochloride
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Patients with invasive ductal pancreatic cancer.
2)Patients with resection of the primary lesion and final findings stage III or IVa.
3)Patients who is between 20 and 80 years old at the time of enrollment.
4)Patients with ECOG Performance Status Scale of 0 or 1.
5)Patients without receiving chemotherapy, radiation therapy and immunotherapy including the treatment for the other carcinoma.
6)Patients who can take medicine orally.
7)Patients who maintain function of main organ in clinical test within 14 days before enrollment.
8)Patients with starting the immunochemotherapy within 2 weeks after enrollment.
9)Patients who have given consent to participate in this clinical study.
1) Active double cancer.
2) Patients with severe myelosuppression.
3) Patients who receiving radiation therapy to the chest.
4) Patients with severe infection.
5) Patients with pulmonary fibrosis or interstitial lung disease.
6) Pregnant patients.
7) Patients with insanity or psychological symptom.
20
1st name | |
Middle name | |
Last name | Shinji Uemoto |
Kyoto University Hospital
Department of Hepato-Pancreatic Surgery & Transplantation
54 Kawara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, JAPAN
1st name | |
Middle name | |
Last name | Kyoichi Takaori |
Kyoto University Hospital
Department of Hepato-Pancreatic Surgery & Transplantation
54 Kawara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, JAPAN
takaori@kuhp.kyoto-u.ac.jp
Kyoto University Hospital
none
Other
NO
京都大学医学部附属病院(京都府)
京都警察病院(京都府)
2010 | Year | 06 | Month | 30 | Day |
Unpublished
Preinitiation
2010 | Year | 06 | Month | 10 | Day |
2010 | Year | 07 | Month | 01 | Day |
2013 | Year | 06 | Month | 01 | Day |
2010 | Year | 06 | Month | 14 | Day |
2010 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004546
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