Unique ID issued by UMIN | UMIN000027389 |
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Receipt number | R000031281 |
Scientific Title | Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology |
Date of disclosure of the study information | 2017/05/19 |
Last modified on | 2019/06/06 19:25:14 |
Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Japan |
Gastric cancer with peritoneal metastasis or positive peritoneal cytology.
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and efficacy of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Safety
Safety
Disease control rate.
three year overall survival.
Progression free survival.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 was administered orally at a dose 80mg/m2/day for 14 consecutive days, followed by 7days of rest. PTX was administered intravenou at a dose of 50mg/m2 and intraperitoneal at a dose of 20mg/m2 on days 1 and 8.
20 | years-old | <= |
85 | years-old | > |
Male and Female
1) histologically proven primar gastric adenocarcinoma.
2) Peritneal metastasis and/or cancer cells on peritoneal cytology.
3) Adequate function of important organs (witin 14 days before registration).
Neutrocyte >= 1,000/mm3
Hemoglobin >= 8.0g/dl
Platelet >= 75,000/mm3
serum transaminases < 100U/L
Total Bilirubin <= 3.0mg/dL
Creatinine clearance >= 30ml/min
4) Eastern Cooperative Oncology Group performance status 0-2
5) Age >= 20, < 85 years
6) Written informed consent.
1)The absence of metastasis to distant organ sites except the retroperitoneum, ovary and abdominal lymph nodes.
2)Contraindication to S-1 or paclitaxel.
3)Apparent infection or inflammation.
4)Sever heart disease.
5)Sever complication.
6)Gastrointestinal bleeding requiring blood transfusion repeatedly.
7)Pregnancy, breast feeding or intention to become pregnant.
8)Judeged inappropriate for this trial for other reasons.
15
1st name | |
Middle name | |
Last name | Hirohiko Kuroda |
Tottori University School of Medicine
Division of Surgical Oncology
36-1 Nishi-cho, Yonago, Tottori
0859-38-6567
kuroda-ttr@umin.ac.jp
1st name | |
Middle name | |
Last name | Hirohiko Kuroda |
Tottori University School of Medicine
Division of Surgical Oncology
36-1 Nishi-cho, Yonago, Tottori
0859-38-6567
kuroda-ttr@umin.ac.jp
Tottori University Hospital
Tottori University Hospital
Self funding
NO
2017 | Year | 05 | Month | 19 | Day |
Unpublished
Terminated
2017 | Year | 05 | Month | 01 | Day |
2017 | Year | 05 | Month | 01 | Day |
2017 | Year | 05 | Month | 19 | Day |
2022 | Year | 05 | Month | 31 | Day |
2017 | Year | 05 | Month | 18 | Day |
2019 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031281
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