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Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

NCT03618758 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-12-05

No results posted yet for this study

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.

Conditions

  • Gastric Cancer Stage IV
  • Peritoneal Carcinomatosis
  • Intraperitoneal Paclitaxel
  • mFOLFOX6

Interventions

DRUG

Paclitaxel

Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum Phase 2: Intraperitoneal Paclitaxel with recommended dose

DRUG

mFOLFOX6 regimen

Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • B. Braun Korea Co., Ltd.

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Hyung-Ho Kim, M.D., PhD. · Seoul National University Bundang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-24
Primary Completion
2023-08-31
Completion
2023-12-02

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03618758 on ClinicalTrials.gov