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

JRCT ID: jRCTs061200027

Registered date:09/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Recurrent gastric cancer with peritoneal dissemination
• Date of first enrollment: 09/04/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral administration of S-1 and intravenous and intraperitoneal administration of paclitaxel

Outcome(s)

• Primary Outcome: Progression free survival

Secondary Outcome

- Oveall survival
- Overall survival rate
- Time to treatment failure
- Response rate
- Peritoneal lavage cytology negative rate
- Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Fujihara Yoshiyuki