Unique ID issued by UMIN | UMIN000013109 |
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Receipt number | R000015292 |
Scientific Title | Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients |
Date of disclosure of the study information | 2014/02/21 |
Last modified on | 2022/08/17 12:07:00 |
Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
GAPS study
Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
GAPS study
Japan |
serosa positive gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety of peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
Safety
percent completion of protocol treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
intraperitoneal and intravenous Paclitaxel plus TS-1
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(i) Histologically proven common gastric carcinoma
(ii) Suspected serosa invasive gastric cancer
(iii) There must be an absence of peritoneal metastasis or negative finding from peritoneal washing cytology confirmed by staging laparoscopy
(iv) The patient must have clinically resectable gastric cancer
(v) Tumor invasion of the esophagus must be less than 3 cm,
(vi) Patients must be in the age range 20-75 years
(vii) The Eastern Cooperative Oncology Group performance status must be 0 or 1
(viii) No previous therapy against GC should have been carried out, and no previous chemotherapy, CRT or radiotherapy
(ix) No typical bleeding from GC and stenosis of gastro-intestinal tract should have occurred
(x) Sufficient oral intake is required
(xi) Written informed consent will be obtained from all patients
(xii) Adequate organ functions are required
(i) The occurrence of simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor that is curable with local therapy
(ii) A history of severe drug hypersensitivity
(iii) The presence of active bacterial or fungal infection, and a body temperature over 38 temperature.
(iv) Pregnancy or lactation in women of childbearing potential
(v) Men who wish the partners pregnancy
(vi) The presence of unstable angina, heart failure or a history of myocardial infarction within 6 months
(vii) Patients requiring systemic steroid medication
(viii) Patients requiring the administration of phenytoin or warfarin potassium
(ix) The presence to peptic ulcer or bleeding
(x) The presence of severe diarrhea
(xi) The presence of antigen-positive serum HBs and/or antibody positive serum HVC
(xii) The presence of uncontrollable intestinal paralysis, interstitial pneumonitis or ischemic heart disease
(xiii) Patients determined to be inappropriate for this study
50
1st name | Motohiro |
Middle name | |
Last name | Imano |
Kinki University Faculty of Medicine
Department of Surgery
5898511
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
072-366-0221
imano@med.kindai.ac.jp
1st name | Motohiro |
Middle name | |
Last name | Imano |
Kinki University Faculty of Medicine
Department of Surgery
5898511
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
072-366-0221
imano@med.kindai.ac.jp
Intraperitoneal chemotherapy study group
Intraperitoneal chemotherapy study group
Other
Kindai University
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
072-366-0221
imano@med.kindai.ac.jp
NO
2014 | Year | 02 | Month | 21 | Day |
Unpublished
Completed
2014 | Year | 02 | Month | 20 | Day |
2014 | Year | 01 | Month | 08 | Day |
2014 | Year | 05 | Month | 01 | Day |
2021 | Year | 12 | Month | 31 | Day |
2014 | Year | 02 | Month | 08 | Day |
2022 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015292
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