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Phase II study of intravenous and intraperitoneal paclitaxel combined with S-1 for gastric cancer with peritoneal metastasis

Phase II study of intravenous and intraperitoneal paclitaxel combined with S-1 for gastric cancer with peritoneal metastasis - Phase II study of intravenous and intraperitoneal paclitaxel combined with S-1 for gastric cancer with peritoneal metastasis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002850
Enrollment
56
Registered
2009-12-05
Start date
2009-12-01
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 intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8. S-1 is administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest.

Sponsors

Department of Surgical Oncology, The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <1.5 mg/dl, 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: Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.

Design outcomes

Primary

MeasureTime frame
the 1-year overall survival rate

Secondary

MeasureTime frame
the overall response rate, efficacy against peritoneal metastasis and safety

Countries

Japan

Contacts

Public ContactHironori Ishigami

The University of Tokyo Department of Surgical Oncology

Outcome results

None listed

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