Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6 (IPLUS)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    43
  • sponsor
    Seoul National University Bundang Hospital
Updated on 12 February 2022
platelet count
paclitaxel
cancer
neutrophil count
her-2
gastric cancer
laparoscopy
systemic chemotherapy
adenocarcinoma
intraperitoneal chemotherapy
mfolfox6

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.

Details
Condition Gastric Cancer Stage IV, Peritoneal Carcinomatosis, Intraperitoneal Paclitaxel, mFOLFOX6
Treatment Paclitaxel, mFOLFOX6 regimen
Clinical Study IdentifierNCT03618758
SponsorSeoul National University Bundang Hospital
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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/mm
Hemoglobin level: 8.0g/dL
Platelet Count: 10104/mm
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
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