Peritoneal Metastases, Stomach Neoplasm
Conditions
Brief summary
This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.
Interventions
Aerosolization of chemotherapic agent for intraperitoneal chemotherapy
Sponsors
Hospicare Co., Ltd.
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically diagnosed as gastric adenocarcinoma * Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis * HER-2 negative tumor * 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
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 * History of gastrointestinal surgery * Patients refusing treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended dose | Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks) | Recommended dose of paclitaxel for a phase II trial |
Countries
South Korea
Contacts
Primary ContactSo Hyun Kang
Outcome results
None listed