Unique ID issued by UMIN | UMIN000003201 |
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Receipt number | R000003870 |
Scientific Title | A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma |
Date of disclosure of the study information | 2010/02/17 |
Last modified on | 2019/09/04 15:15:45 |
A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma
chemoradiation therapy for advanced or recurrent gastric adenocarcinoma
A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma
chemoradiation therapy for advanced or recurrent gastric adenocarcinoma
Japan |
gastric cancer
Gastrointestinal surgery |
Malignancy
NO
Evaluation of efficacy of chemoradiation therapy with paclitaxel and cisplatin for local symptoms
due to an unresectable primary advanced or locally
recurrent gastric adenocarcinoma
Efficacy
Phase II
Improvement of gastrointestinal obstruction and/or localized pain
Improved duration of gastrointestinal obstruction , survival time, adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
chemoradiation therapy
with paclitaxel and cisplatin
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histologically confirmed gastric cancer
2) Patients who have local symptoms
due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma
3) Age between 20 to 80 at registration
4) ECOG PS 0 to 1
5) No or one history of chemotherapy for gastric cancer(adjuvant chemotherapy is excluded)
6) No history of chemotherapy with paclitaxel and cisplatin or chemotherapy including cisplatin(over 240mg/m2)
7) 3 weeks after other chemotherapy
8) No history of radiation therapy for left upper abdomen
9) Over 2 months survival is expected
10) adequate organ function
11) No other active malignancy
12) Written informed consent
1) Tumor localization is not detected by neither CT, endoscopy nor upper GI series
2) Serious comorbidities
3) Severe GI obstruction or gastrointestinal bleeding
4) Current inflammation or acute inflammatory disease
5) Allergy to cremophor EL
6) Brain metastasis with symptom
7) Female with present pregnancy or breast-feeding, or contemplating pregnancy.
8) Registered to other clinical trial
9) Patients judged inappropriate for the study by the physicians
20
1st name | Takaki |
Middle name | |
Last name | Yoshikawa |
Kanagawa Cancer Center
Department of Gastrointestinal Surgery
241-8515
1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan
0455202222
takay0218@yahoo.co.jp
1st name | Takanobu |
Middle name | |
Last name | Yamada |
Kanagawa Cancer Center
Department of Gastrointesitnal Surgery
241-8515
1-1-2 Nakao Asahi-Ku, Yokohama 241-0815, Japan
0455202222
takay0218@yahoo.co.jp
Study group of multi-modality therapy for gastric cancer
Kanagawa standard anti-cancer therapy support system (KSATSS)
Other
Kanagawa Cancer Center
2-3-2 Nakao Asahi Yokohama Kanagawa Japan
0455202222
takay0218@yahoo.co.jp
NO
2010 | Year | 02 | Month | 17 | Day |
None
Unpublished
None
5
This trial was terminated, because sufficient number of patients enrolled.
2019 | Year | 09 | Month | 04 | Day |
Impossible to evaluate
Impossible to evaluate
Impossible to evaluate
Impossible to evaluate
Terminated
2008 | Year | 03 | Month | 12 | Day |
2019 | Year | 02 | Month | 22 | Day |
2009 | Year | 04 | Month | 01 | Day |
2017 | Year | 08 | Month | 31 | Day |
2017 | Year | 09 | Month | 30 | Day |
2017 | Year | 09 | Month | 30 | Day |
2010 | Year | 02 | Month | 17 | Day |
2019 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003870
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