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Phase II study of intraperitoneal docetaxel combined with capecitabine plus cisplatin for advanced gastric cancer with peritoneal metastasis

Phase II study of intraperitoneal docetaxel combined with capecitabine plus cisplatin for advanced gastric cancer with peritoneal metastasis - Phase II study of XP+IP DOC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016469
Enrollment
50
Registered
2015-04-01
Start date
2015-04-01
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

Docetaxel is administered intraperitoneally at 10 mg/m2 on days 1 and 8. Capecitabine is administered at 2,000 mg/m2/day for 14 consecutive days, followed by 7 days rest. Cisplatin is administered

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable gastric adenocarcinoma with peritoneal metastasis; age between 20 and 75 years; Eastern Cooperative Oncology Group performance status 0-1; adequate bone marrow function (leukocyte count LLN-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <ULNx1.5, serum transaminases <100/UI); adequate renal function (creatinine clearance >60mL/min); 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
1-year overall survival

Secondary

MeasureTime frame
response rate negative conversion rate on peritoneal cytology safety

Countries

Japan

Contacts

Public ContactHironori Ishigami

The University of Tokyo Department of Chemotherapy

ishigami-tky@umin.net03-3815-5411

Outcome results

None listed

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