Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

Peritoneal Carcinomatosis Clinical Trial

— IPLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618758
• Other study ID #: SNUBH_GS_IPEC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 24, 2018
• Est. completion date: December 2, 2023

Study information

• Verified date: December 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Gastric Cancer Stage IV
• Intraperitoneal Paclitaxel
• mFOLFOX6
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	B. Braun Korea Co., Ltd., Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose determination (Phase 1)	Dosage determination of Intraperitoneal Paclitaxel	1 Year
Primary	Overall survival (Phase 2)	1 year Overall survival with determined dose from Phase 1	1 Year
Secondary	Progression-free survival	1 year Progression-free survival	1 Year
Secondary	Toxicity ratio	Toxicity occurrence ratio by CTCAE V.4	3 Years
Secondary	Tumor response	Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system	3 Years
Secondary	Conversion surgery ratio	Conversion surgery after stable disease or regression	3 Years