PR-PHOENIX trial

JRCT ID: jRCTs031180025

Registered date:12/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastric cancer with peritoneal metastasis or positive peritoneal cytology
• Date of first enrollment: 12/10/2018
• Target sample size: 121
• Study type: Interventional
• Intervention(s): intraperitoneal PTX 20 mg/m2, intravenous PTX 50 mg/m2 on days 1 and 8, S-1 80 mg/m2/day on days 1-14, q3 weeks

Outcome(s)

• Primary Outcome: safety
• Secondary Outcome: overall survival, response rate, negative conversion rate on peritoneal cytology

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 84age old
• Gender: Both

Include criteria

1) Pathologically proven primary gastric adenocarcinoma
2) Peritoneal metastasis or positive peritoneal cytology
3) Adequate function of important organs (within 14 days before registration)
NEU >=1,000/mm3
Hemoglobin >=8.0g/dL
Platelet >=75,000/mm3
AST <=150U/L, ALT <=150U/L
T-Bilirubin <=3.0mg/dL
Creatinine clearance >=30mL/min
4) Eastern Cooperative Oncology Group performance status 0-3
5) Age >=20, <85
6) Written informed consent

Exclude criteria

1) Distant metastasis other than peritoneal, ovarian and abdominal lymph node metastasis
2) Contraindication to S-1 or paclitaxel
3) Apparent infection or inflammation
4) Severe heart disease
5) Severe complication
6) Gastrointestinal tract bleeding requiring blood transfusion
7) Pregnancy, breast feeding or intention to become pregnant
8) Judged inappropriate for this trial for other reasons

Related Information

• Primary Sponsor: Ishigami Hironori
• Secondary ID(s): UMIN000023620