Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis

Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis - Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013528

Enrollment

Registered

2014-04-01

Start date

2014-04-10

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

Interventions

Paclitaxel is administered intraperitoneally on days 1, 8 and 22. S-1 is administered for 21 consecutive days, followed by 14 days rest. Cisplatin is administered on day8.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable gastric adenocarcinoma; peritoneal metastasis; age between 20 and 75 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count the lower limit of normal-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin < 1.5 * the upper limit of normal, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.

Exclusion criteria

Exclusion criteria: Other active concomitant malignancies, massive ascites or other severe medical conditions.

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
negative conversion rate on peritoneal cytology	—

Countries

Japan

Contacts

Public ContactDaisuke Kobayashi

Nagoya University, Graduate School of Medicine Department of Gastroenterology

kobadai@med.nagoya-u.ac.jp052-744-2249

Outcome results

None listed

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