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Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

NCT ID: NCT03618758

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-24

Study Completion Date

2023-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Stage IV Peritoneal Carcinomatosis Intraperitoneal Paclitaxel mFOLFOX6

Keywords

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Gastric cancer Peritoneal carcinomatosis Intraperitoneal chemotherapy Paclitaxel FOLFOX

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric Cancer with Peritoneal Carcinomatosis

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

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type 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

mFOLFOX6 regimen

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

mFOLFOX6 regimen

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

Intervention Type DRUG

Other Intervention Names

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(Genexol®)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role collaborator

B. Braun Korea Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Ho Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyung-Ho Kim, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUBH_GS_IPEC

Identifier Type: -

Identifier Source: org_study_id