PR-PHOENIX trial

Phase 2

• Conditions: gastric cancer with peritoneal metastasis or positive peritoneal cytology

• Registration Number: JPRN-jRCTs031180025
• Lead Sponsor: Ishigami Hironori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-12
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 121

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety

Secondary Outcome Measures

Name	Time	Method
overall survival, response rate, negative conversion rate on peritoneal cytology