Unique ID issued by UMIN | UMIN000003795 |
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Receipt number | R000004517 |
Scientific Title | Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer |
Date of disclosure of the study information | 2010/06/22 |
Last modified on | 2014/05/08 14:44:38 |
Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer
Phase I study of preoperative chemo-radiotherapy in patients with pancreatic cancer
Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer
Phase I study of preoperative chemo-radiotherapy in patients with pancreatic cancer
Japan |
pancreatic cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and feasibilty for S1 and radiotherapy as neoadjuvant against pancreatic cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase I
Safety,Efficacy
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
2
Treatment
Medicine |
preoperative chemoradiotherapy with 1 course of S-1
preoperative chemoradiotherapy with 2course of S-1
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Confirmed boarder-line resectable pancreatic cancer as adenocarcinoma by histological, cytological, or radiological examinations
2)Confirmed target region
3)No prior treatment
4)Age 20-80
5)PS 0/1
6)Adequate organ functions
neutrophils >=1,500/mm3
leukocytes >=4,000/mm3, =<12,000/mm3
platelets >=100,000/mm3
hemoglobin >=10.0g/dL
AST(GOT)/ALT(GPT)/ALP within 3 times of normal limits
total bilirubin <=1.5mg/dL
BUN <= 25mg/dl
serum creatinine <=1.5mg/dL
creatinine clearance >=50mL/min
6)PS(ECOG) 0-2
7)Sufficient oral intake
8)With written informed consent
9)Estimated life expectancy of at least 3 months
1)Active double cancer
2)Severe diarrhea
3)Symptomatic pulmonary fibrosis or interstitial pneumonia. Marked pleural or peritoneal effusion
4)Metastasis in central nervous system
5)para-aortic lymph node metastasis
6)Severe complications, such as ileus, heart failure and renal failure
7)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
8)History of severe anaphylaxies
9)Active infection
10)Severe mental disorder
11)Patients under treatment with flucytosine, phenytoin or warfarin potassium
12)Inadequate physical condition, as diagnosed by primary physician
12
1st name | |
Middle name | |
Last name | Masaji Tani |
Wakayama Medical University, School of Medicine
Second Department of Surgery
811-1 Kimiidera,Wakayama 641-8510, Japan
073-447-2300
srg2@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Masaji Tani |
Wakayama Medical University, School of Medicine
Second Department of Surgery
811-1 Kimiidera,Wakayama 641-8510, Japan
073-447-2300
srg2@wakayama-med.ac.jp
Wakayama Medical University, School of Medicine
None
Self funding
NO
2010 | Year | 06 | Month | 22 | Day |
Unpublished
Completed
2010 | Year | 04 | Month | 16 | Day |
2010 | Year | 05 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2010 | Year | 06 | Month | 21 | Day |
2014 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004517
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