Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

Phase 1

Completed

• Conditions: Gastric Cancer Stage IV; Peritoneal Carcinomatosis; Intraperitoneal Paclitaxel; mFOLFOX6
• Interventions: Drug: Paclitaxel; Drug: mFOLFOX6 regimen

• Registration Number: NCT03618758
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-07
• Study Start: 2018-12-24
• Primary Completion: 2023-08-31
• Status Verified: 2023-12
• Study Completion: 2023-12-02
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric Cancer with Peritoneal Carcinomatosis	Paclitaxel	Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
Gastric Cancer with Peritoneal Carcinomatosis	mFOLFOX6 regimen	Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)

Primary Outcome Measures

Name	Time	Method
Dose determination (Phase 1)	1 Year	Dosage determination of Intraperitoneal Paclitaxel
Overall survival (Phase 2)	1 Year	1 year Overall survival with determined dose from Phase 1

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	1 Year	1 year Progression-free survival
Toxicity ratio	3 Years	Toxicity occurrence ratio by CTCAE V.4
Tumor response	3 Years	Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system
Conversion surgery ratio	3 Years	Conversion surgery after stable disease or regression

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of