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Intraperitoneal and intravenous paclitaxel plus S-1 in patients with gastric cancer with peritoneal metastasis (Intraperitoneal and intravenous paclitaxel plus S-1 in patients with gastric cancer with peritoneal metastasis)

Intraperitoneal and intravenous paclitaxel plus S-1 (Intraperitoneal and intravenous paclitaxel plus S-1)

Fujiwara Yoshiyuki

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori

y-fujiwara@med.tottori-u.ac.jp

Miyatani Kozo

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori

+81-859-38-6567

kozo5963@tottori-u.ac.jp

Not Recruiting

May. 01, 2017

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) histologically proven primar gastric adenocarcinoma.
2) Peritneal metastasis and/or cancer cells on peritoneal cytology.
3) Patients with following adequate function of important organs at screening period.
Neutrocyte >= 1,000/mm3
Hemoglobin >= 8.0g/dl
Platelet >= 75,000/mm3
AST, ALT < 150U/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)Inappropriate for this trial for other reasons.

Both

Gastric cancer with peritoneal metastasis or positive peritoneal cytology.

S-1 was administered orally at a dose 80mg/m2/day for 14 consecutive days, followed by 7 days of rest. PTX was administered intravenous at a dose of 50mg/m2 and intraperitoneal at a dose of 20mg/m2 on days 1 and 8.

C16

Safety(Adverse experience. Laboratory tests. Vital sign)

1) Disease control rate.
2) Three year overall survival.
3) Progression free survival.
4) Usefulness of peritoneal cancer index (PCI) as a prognostic indicator.
5) Usefulness of the presence or absence of negative conversion of cytology as a prognostic indicator.

+81-859-38-7021

Nov. 30, 2018

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