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

JRCT ID: jRCTs041180079

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 14/04/2017
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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/m2 on day8.

Outcome(s)

• Primary Outcome: 1-year overall survival rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Kodera Yasuhiro
• Secondary Sponsor: Kitayama Jyoji
• Source(s) of Monetary Support: Japan Society of Clinical Oncology