Clinical Trial: NCT03618758 - My Cancer Genome

NCT03618758

Description:

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.

Related Conditions:

Gastric Adenocarcinoma

Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03618758

Trial Eligibility

Document

Title

Brief Title: Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Official Title: Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy

Clinical Trial IDs

ORG STUDY ID: SNUBH_GS_IPEC
NCT ID: NCT03618758

Conditions

Gastric Cancer Stage IV
Peritoneal Carcinomatosis
Intraperitoneal Paclitaxel
mFOLFOX6

Interventions

Drug	Synonyms	Arms
Paclitaxel	(Genexol®)	Gastric Cancer with Peritoneal Carcinomatosis
mFOLFOX6 regimen		Gastric Cancer with Peritoneal Carcinomatosis

Purpose

Trial Arms

Name	Type	Description	Interventions
Gastric Cancer with Peritoneal Carcinomatosis	Experimental	Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)	Paclitaxel mFOLFOX6 regimen

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

Maximum Eligible Age:	79 Years
Minimum Eligible Age:	20 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Dose determination (Phase 1)
Time Frame:	1 Year
Safety Issue:
Description:	Dosage determination of Intraperitoneal Paclitaxel

Secondary Outcome Measures

Measure:	Progression-free survival
Time Frame:	1 Year
Safety Issue:
Description:	1 year Progression-free survival

Measure:	Toxicity ratio
Time Frame:	3 Years
Safety Issue:
Description:	Toxicity occurrence ratio by CTCAE V.4

Measure:	Tumor response
Time Frame:	3 Years
Safety Issue:
Description:	Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system

Measure:	Conversion surgery ratio
Time Frame:	3 Years
Safety Issue:
Description:	Conversion surgery after stable disease or regression

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Seoul National University Bundang Hospital

Trial Keywords

Gastric cancer
Peritoneal carcinomatosis
Intraperitoneal chemotherapy
Paclitaxel
FOLFOX

Last Updated

March 9, 2021

Clinical Trials /

Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6