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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027389
Enrollment
15
Registered
2017-05-19
Start date
2017-05-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer with peritoneal metastasis or positive peritoneal cytology.

Interventions

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 d

Sponsors

Tottori University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Disease control rate. three year overall survival. Progression free survival.

Countries

Japan

Contacts

Public ContactHirohiko Kuroda

Tottori University School of Medicine Division of Surgical Oncology

kuroda-ttr@umin.ac.jp0859-38-6567

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026