Unique ID issued by UMIN | UMIN000002988 |
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Receipt number | R000003613 |
Scientific Title | A Phase II Study of Paclitaxel+Cisplatin+5-Fluorouracil in Unresectable Advanced or Recurrent Gastric Cancer |
Date of disclosure of the study information | 2010/01/06 |
Last modified on | 2010/01/05 17:31:10 |
A Phase II Study of Paclitaxel+Cisplatin+5-Fluorouracil in Unresectable Advanced or Recurrent Gastric Cancer
TCF-P2
A Phase II Study of Paclitaxel+Cisplatin+5-Fluorouracil in Unresectable Advanced or Recurrent Gastric Cancer
TCF-P2
Japan |
Unresectable Advanced or Recurrent Gastric Cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
The present multicenter phase II study was conducted to confirm the efficacy of paclitaxel/cisplatin/5-FU in advanced gastric cancer.
Safety
Response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
paclitaxel+cisplatin+5-FU
20 | years-old | <= |
Not applicable |
Male and Female
a) pathologically confirmed gastric carcinoma
b)measurable lesion(s)
c) absence of any history of treatment with taxanes, platinum-based compounds, or 5-fluorouracil (one regimen of pretreatment with oral 5-fluorouracil agents was allowed)
d) ECOG PS 0-2
e) adequate organ function
f) written informed consent.
a) serious complications e.g. ischemic heart disease which is in need of treatment
b) myocardial infarction developed within 6 momnths
c) liver cirrhosis
d) interstitial pneumonitis or pulmonary fibrosis which is in need of oxygen therapy
e) fresh GI bleeding treated with repeated transfusion
f) uncontrollable DM
h) ileus
40
1st name | |
Middle name | |
Last name | Kenji Omura |
Kanazawa University
Genneral and Cardiopulmonary Surgery
13-1 Takaramachi, Kanazawa, 920-8641 JAPAN
1st name | |
Middle name | |
Last name |
Nagoya Graduate Scholl of Medicine
Department of Social Life Science
052-744-2442
Non profit foundation: Epidemiological and Clinical Research Information Network
Non profit foundation: Epidemiological and Clinical Research Information Network
Non profit foundation
NO
2010 | Year | 01 | Month | 06 | Day |
Unpublished
Completed
2006 | Year | 01 | Month | 13 | Day |
2006 | Year | 01 | Month | 01 | Day |
2010 | Year | 01 | Month | 06 | Day |
2010 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003613
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