Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6 (IPLUS)

December 2, 2023 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital

Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastric Cancer with Peritoneal Carcinomatosis
Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
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

Other Names:
  • (Genexol®)
Drug: mFOLFOX6 regimen
Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose determination (Phase 1)
Time Frame: 1 Year
Dosage determination of Intraperitoneal Paclitaxel
1 Year
Overall survival (Phase 2)
Time Frame: 1 Year
1 year Overall survival with determined dose from Phase 1
1 Year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Boryung Pharmaceutical Co., Ltd
B. Braun Korea Co., Ltd.

Investigators

  • Principal Investigator: Hyung-Ho Kim, M.D., PhD., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2018

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

December 2, 2023

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_GS_IPEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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