This phase II trial tests how well concentrating heated (hyperthermic) chemotherapy in the area that contains the abdominal organs (intraperitoneal \[IP\]) at the time of surgery works in treating patients with gastric or gastroesophageal junction adenocarcinoma at high risk of the cancer coming back to the abdominal cavity (peritoneal) after a period of improvement (recurrence). Recurrence in the peritoneum often occurs within the first 18 months after surgery. This is thought to be due to tumor cells that may scatter and spread during surgery. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Paclitaxel alone and in combination with other chemotherapy agents have been shown to be effective treatments for gastric tumors. However, systemic delivery of these drugs has not been shown to be effective in treating peritoneal metastasis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure that involves the infusion of a heated chemotherapy solution, such as cisplatin and paclitaxel, that circulates into the abdominal cavity. Giving HIPEC with cisplatin and paclitaxel at the time of surgery may reduce peritoneal recurrence in patients with gastric or gastroesophageal junction adenocarcinoma at high risk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Undergo laparoscopy with biopsy
Undergo blood sample collection
Given IP
Undergo PET/CT
Given p-HIPEC
Undergo laparoscopy with biopsy
Undergo D2 lymphadenectomy
Undergo PET/MRI
Given IP
Undergo PET/CT or PET/MRI
Undergo gastrectomy and reconstruction
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Peritoneal Recurrence-free Survival
Patients will be followed in active surveillance with biomarkers (CEA and CA 19-9) and cross-sectional imaging of the chest, abdomen and pelvis. Only non-lymphatic, non-peranastomotic, and non-visceral intra-abdominal metastasis will be considered peritoneal metastasis. Ovarian metastasis will be considered peritoneal metastasis for this trial.
Time frame: Up to 18 months
Safety and Tolerability (Adverse Events)
Safety and tolerability will be determined by incidence of adverse events (AEs), specifically the incidence of grade 3 neutropenia and thrombocytopenia. AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence of acute kidney injury will be defined by the glomerular filtration rate (GFR) criteria of the Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease (RIFLE) classification.
Time frame: Up to 45 days after study treatment
Recurrence-free Survival
Recurrence-free survival (RFS) is defined as the time from study entry to the first of either disease progression or death due to any cause. Any radiographic, endoscopic or biopsy proven recurrence of cancer will count as disease recurrence.
Time frame: Up to 5 years
Overall Survival
Overall survival (OS) is defined as the time from date of study entry to date of death or last follow up.
Time frame: 3 years and 5 years
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