Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results.

This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborators: B. Braun Korea Co., Ltd.; Boryung Pharmaceutical Co., Ltd
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Biopsy proven adenocarcinoma of gastric origin, primary or recurrent

• Identification of Peritoneal seeding by CT or diagnostic laparoscopy

• Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic

• No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer

• Labs adequate for chemotherapy (within 2 weeks of enrollment)

• Absolute Neutrophil Count: ≧ 1,500/mm³

• Hemoglobin level: ≧ 8.0g/dL

• Platelet Count: ≧ 10×104/mm³

• AST (GOT), ALT (GPT): ≦ 100U/L

• Total Bilirubin: ≦ 2.0mg/dL

• Creatinine Clearance (CCl): ≧ 50mL/min

• ECOG 0 - 2

• Her-2 negative on endoscopic biopsy

• Age ≧ 20, < 80

• Signed Informed consent form

Exclusion Criteria:

• Patients with other major medical disease or malignant tumors other than gastric cancer

• Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel

• Pregnant, breast-feeding women or with birth plan

• Patients refusing treatment