NCT03618758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 24, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

4.7 years

First QC Date

August 2, 2018

Last Update Submit

December 2, 2023

Conditions

Gastric Cancer Stage IVPeritoneal CarcinomatosisIntraperitoneal PaclitaxelmFOLFOX6

Keywords

Gastric cancerPeritoneal carcinomatosisIntraperitoneal chemotherapyPaclitaxelFOLFOX

Outcome Measures

Primary Outcomes (2)

  • Dose determination (Phase 1)

    Dosage determination of Intraperitoneal Paclitaxel

    1 Year

  • Overall survival (Phase 2)

    1 year Overall survival with determined dose from Phase 1

    1 Year

Secondary Outcomes (4)

  • Progression-free survival

    1 Year

  • Toxicity ratio

    3 Years

  • Tumor response

    3 Years

  • Conversion surgery ratio

    3 Years

Study Arms (1)

Gastric Cancer with Peritoneal Carcinomatosis

EXPERIMENTAL

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

Drug: PaclitaxelDrug: mFOLFOX6 regimen

Interventions

PaclitaxelDRUG

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

Also known as: (Genexol®)
Gastric Cancer with Peritoneal Carcinomatosis
mFOLFOX6 regimenDRUG

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

Gastric Cancer with Peritoneal Carcinomatosis

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Stomach NeoplasmsPeritoneal Neoplasms

Interventions

Paclitaxelgenexol-PM

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesAbdominal NeoplasmsPeritoneal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Hyung-Ho Kim, M.D., PhD.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 7, 2018

Study Start

December 24, 2018

Primary Completion

August 31, 2023

Study Completion

December 2, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

KR(1)