Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6 (IPLUS)

Seoul National University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Intraperitoneal Paclitaxel

Gastric Cancer Stage IV

mFOLFOX6

Peritoneal Carcinomatosis

Treatments

Drug: mFOLFOX6 regimen

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03618758

SNUBH_GS_IPEC

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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