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Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6 (IPLUS)

Primary Purpose

Gastric Cancer Stage IV, Peritoneal Carcinomatosis, Intraperitoneal Paclitaxel

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel
mFOLFOX6 regimen
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer Stage IV focused on measuring Gastric cancer, Peritoneal carcinomatosis, Intraperitoneal chemotherapy, Paclitaxel, FOLFOX

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric Cancer with Peritoneal Carcinomatosis

Arm Description

Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2018
Last Updated
March 7, 2021
Sponsor
Seoul National University Bundang Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd, B. Braun Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03618758
Brief Title
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Acronym
IPLUS
Official Title
Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd, B. Braun Korea Co., Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer Stage IV, Peritoneal Carcinomatosis, Intraperitoneal Paclitaxel, mFOLFOX6
Keywords
Gastric cancer, Peritoneal carcinomatosis, Intraperitoneal chemotherapy, Paclitaxel, FOLFOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric Cancer with Peritoneal Carcinomatosis
Arm Type
Experimental
Arm Description
Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
(Genexol®)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 regimen
Intervention Description
Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)
Primary Outcome Measure Information:
Title
Dose determination (Phase 1)
Description
Dosage determination of Intraperitoneal Paclitaxel
Time Frame
1 Year
Title
Overall survival (Phase 2)
Description
1 year Overall survival with determined dose from Phase 1
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
1 year Progression-free survival
Time Frame
1 Year
Title
Toxicity ratio
Description
Toxicity occurrence ratio by CTCAE V.4
Time Frame
3 Years
Title
Tumor response
Description
Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system
Time Frame
3 Years
Title
Conversion surgery ratio
Description
Conversion surgery after stable disease or regression
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sa-Hong Min, M.D.
Phone
82-31-787-6450
Email
shmin823@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D., PhD.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sa-Hong Min, M.D.
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D., PhD.
First Name & Middle Initial & Last Name & Degree
Do Joong Park, M.D., PhD.
First Name & Middle Initial & Last Name & Degree
Sang-Hoon Ahn, M.D.
First Name & Middle Initial & Last Name & Degree
Young Suk Park, M.D.
First Name & Middle Initial & Last Name & Degree
Yo Seok Cho, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

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