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OpenTrials
Completed

NCT Number: NCT03618758

Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

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.

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Key information

Conditions

Gastric Cancer Stage IV Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intraperitoneal Paclitaxel Neoplasms Neoplasms by Site Peritoneal Carcinomatosis Peritoneal Diseases Peritoneal Neoplasms Stomach Diseases Stomach Neoplasms mFOLFOX6

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

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®)

mFOLFOX6 regimen

Drug

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

Primary outcomes

  1. Dose determination (Phase 1)

    Time frame: 1 Year

    Dosage determination of Intraperitoneal Paclitaxel

  2. Overall survival (Phase 2)

    Time frame: 1 Year

    1 year Overall survival with determined dose from Phase 1

Secondary outcomes

  1. Progression-free survival

    Time frame: 1 Year

    1 year Progression-free survival

  2. Toxicity ratio

    Time frame: 3 Years

    Toxicity occurrence ratio by CTCAE V.4

  3. Tumor response

    Time frame: 3 Years

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

  4. Conversion surgery ratio

    Time frame: 3 Years

    Conversion surgery after stable disease or regression

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: IPLUS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2018
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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