Unique ID issued by UMIN | UMIN000004504 |
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Receipt number | R000005374 |
Scientific Title | A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01) |
Date of disclosure of the study information | 2010/11/15 |
Last modified on | 2016/05/09 22:04:13 |
A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01)
A phase II study of portal infusion chemotherapy followed by gemcitabine for resected pancreatic cancer (TOSPAC-01)
A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01)
A phase II study of portal infusion chemotherapy followed by gemcitabine for resected pancreatic cancer (TOSPAC-01)
Japan |
Resected pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the feasibility and efficacy of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with pancratic cancer after surgery
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Disease free survival
Incidence of severe adverse events
Overall survival
Incidence of adverse events
Proportion of treatment completion
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
With adjuvant chemotherapy of 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine after surgery
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Histologically proven invasive ductal carcinoma of the pancreas
2) Macroscopically curative resection (R0, R1)
3) No history of prior chemotherapy or radiotherapy for pancreatic cancer except pancreatectomy
4) ECOG PS: 0-1
5) Sufficient organ functions before surgery
WBC > 4,000/mm3
Neutrophil > 2,000/mm3
Plt > 100,000/mm3
Hb > 9 g/dl
AST, ALT < 5 times the upper limit of the normal range
Serum creatinine < the upper limit of the normal range
6) Placement of the catheter for portal infusion chemotherapy within the portal vein
7) Written informed consent
1) Pulmonary fibrosis or interstitial pneumonia
2) Uncontrolled pleural effusion
3) Resection of the distant organ metastasis
4) Active double cancer
5) Active infection
6) History of serious complications related to surgery
7) Active peptic ulcer
8) History of myocardial infarction within three months
9) Severe mental disorder
10) Pregnant or breast feeding
11) Patients judged inappropriate for the study by the physicians
50
1st name | |
Middle name | |
Last name | Minoru Kitago |
Keio University School of Medicine
Department of Surgery
35, Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
contact@keio-hpbts.jp
1st name | |
Middle name | |
Last name | Minoru Kitago |
Keio University School of Medicine
Department of Surgery
35, Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
contact@keio-hpbts.jp
Tokyo Study Group for Pancreatic Cancer (TOSPAC)
None
Self funding
NO
2010 | Year | 11 | Month | 15 | Day |
Partially published
No longer recruiting
2010 | Year | 08 | Month | 18 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 04 | Day |
2016 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005374
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