Clincosm LogoSign in Get a demo

IPLUS: Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03618758
Collaborator
Boryung Pharmaceutical Co., Ltd (Industry), B. Braun Korea Co., Ltd. (Industry)
43
Enrollment
1
Location
1
Arm
60.2
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy
Actual Study Start Date :
Dec 24, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Dose determination (Phase 1) [1 Year]

      Dosage determination of Intraperitoneal Paclitaxel

    2. Overall survival (Phase 2) [1 Year]

      1 year Overall survival with determined dose from Phase 1

    Secondary Outcome Measures

    1. Progression-free survival [1 Year]

      1 year Progression-free survival

    2. Toxicity ratio [3 Years]

      Toxicity occurrence ratio by CTCAE V.4

    3. Tumor response [3 Years]

      Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system

    4. Conversion surgery ratio [3 Years]

      Conversion surgery after stable disease or regression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital
    • Boryung Pharmaceutical Co., Ltd
    • B. Braun Korea Co., Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyung-Ho Kim, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT03618758
    Other Study ID Numbers:
    • SNUBH_GS_IPEC
    First Posted:
    Aug 7, 2018
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Hyung-Ho Kim, Professor, Seoul National University Bundang Hospital
    Gastric cancer
    Peritoneal carcinomatosis
    Intraperitoneal chemotherapy
    Paclitaxel
    FOLFOX
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Carcinoma
    Peritoneal Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Mar 9, 2021