Clinical research of intraperitoneal and intravenous paclitaxel plus S-1 in patients with recurrence of gastric cancer with peritoneal disseminatio

Phase 2

Recruiting

• Conditions: Recurrent gastric cancer with peritoneal dissemination

• Registration Number: JPRN-jRCTs061200027
• Lead Sponsor: Fujihara Yoshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Patients whose peritoneal dissemination was confirmed by image diagnosis or examination laparoscopy after radical resection (R0) for gastric adenocarcinoma.
2) Patients with following adequate function of important organs at screening period.
a) Neutrocyte >= 1,000/mm3
b) Hemoglobin >= 8.0g/dl
c) Platelet >= 75,000/mm3
d) AST, ALT < 100U/L
e) Total Bilirubin <= 2.0mg/dL
f) Creatinine clearance >= 30ml/min
3) ECOG PS with 0-2.
4) Age >= 20, < 85 years at consent form.

Exclusion Criteria

1) Patinets with absence of metastasis to distant organ sites except ovary.
2) Patients who are contraindicated for S-1 or paclitaxel.
3) Patients with experience of using taxane anticancer drugs for unresectable/Recurrent gastric cancer.
4) Patients with peritoneal recurrence within 3 months after S-1 adjuvant chemotherapy.
5) Patients with concurrent double cancer at registration.
6) Patients with serious complications.
7) Patients with pregnancy, breast feeding or intention to become pregnant.
8) Patients who participated in other clinical studies within 3 months before registration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified