Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer

Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients with Peritoneal Metastasis

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0007061

Enrollment

Registered

2022-03-08

Start date

2021-09-15

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Paclitaxel (Genexol) - Pressurized Intraperitoneal Aerosol Chemotherapy - Normal Saline 150 ml + Paclitaxel (dose titration) - About every 6-7 weeks (after every 3 cycles of systemic chemothera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Pathologically diagnosed as gastric adenocarcinoma - Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis - Patients set to undergo FOLFOX as systemic chemotherapy regimen after a multidisciplinary meeting - Laboratory tests 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 tumor - age of or over 20 and less than 80 years - agreed to the informed consent

Exclusion criteria

Exclusion criteria: 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 - Patients who are totally dependent on parenteral nutrition - Having allergies to anticancer agents - Who have anticipated lifespan of less than 3 months - Small bowel ileus - Distant metastasis in other organs (except lymph nodes and Krukenberg/ovaries)

Design outcomes

Primary

Measure	Time frame
Recommended phase II dose for PIPAC Paclitaxel	—

Secondary

Measure	Time frame
Survival (1-year overall survival and progression-free survival), tumor response, peritoneal metastasis response, conversion surgery rate	—

Countries

Korea, Republic of

Contacts

Public ContactSo Hyun Kang

Seoul National University Bundang Hospital

emotipe3@gmail.com+82-31-787-7099

Outcome results