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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012971
Enrollment
12
Registered
2014-01-27
Start date
2014-01-24
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 on days 1 and 8. Capecitabine is administered for 14 consecutive days, followed by 7 days rest. Cisplatin is administered on day1.

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis; age between 20 and 75 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >9.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <2.0 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: Other active concomitant malignancies, massive ascites or other severe medical conditions.

Design outcomes

Primary

MeasureTime frame
safety

Secondary

MeasureTime frame
negative conversion rate on peritoneal cytology

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