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Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for advanced gastric cancer with peritoneal metastasis

Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for advanced gastric cancer with peritoneal metastasis - S-1/CDDP + IP PTX Phase 2 (SP + IP PTX)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180079
Enrollment
50
Registered
2019-03-11
Start date
2017-04-14
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 Gastric cancer, peritoneal metastasis

Interventions

Paclitaxel is administered intraperitoneally at 20 mg/m2 on days 1,8 and 22. S-1 is administered at 80 mg/m2/day for 21 consecutive days, followed by 14 days-rest. Cisplatin is administered at 60 mg/

Sponsors

Kodera Yasuhiro
Lead Sponsor
Kitayama Jyoji
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven unresectable or recurrent gastric adenocarcinoma 2) Peritoneal metastasis 3) No prior chemotherapy 4) Adequate bone marrow function 5) Eastern Cooperative Oncology Group performance status 0-1 6) An expected survival period of more than 3 months 7) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Metastasis to distant organ sites (such as the liver, lungs or bone) 2) Other active concomitant malignancies 3) other severe medical conditions; pregnant 4) unwilling to practice contraception during the study, or lactating female

Design outcomes

Primary

MeasureTime frame
1-year overall survival rate

Secondary

MeasureTime frame
Progression-free survival, time to treatment failure, response rate, negative conversion rate on peritoneal cytology, safety, 2-year overall survival rate, 3-year overall survival rate

Contacts

Public ContactDaisuke Kobayashi

Nagoya University Hospital

kobadai@med.nagoya-u.ac.jp+81-52-744-2249

Outcome results

None listed

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