A Phase II Single Arm Study of Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Mohammad Haroon Asif Choudry
Summary
This trial will administer laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with peritoneal carcinomatosis from gastric cancer (GPC) who are receiving standard of care systemic chemotherapy.
Description
Patients with peritoneal carcinomatosis from gastric cancer (GPC) have dismal oncologic outcomes, with median survival duration of 6-12 months and 2-year overall survival rate of \< 10%. Despite advancements in systemic therapy, survival remains poor and most patients succumb to the disease within 4-11 months following diagnosis. Therefore, there is a substantial need for novel treatment strategies to improve oncologic outcomes in GPC. The primary intervention is the addition of iterative laparoscopic HIPEC to the ongoing standard systemic chemotherapy regimen (or at least the backbone regimen…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically proven, synchronous gastric and/or gastroesophageal junction (Siewert 3) adenocarcinoma with either positive peritoneal cytology (micPC) or macroscopic carcinomatosis (macPC) (stage IV), diagnosed by imaging or laparoscopy or laparotomy. * Patients must be 18 years of age or older at time of informed consent. * ECOG performance status of ≤ 2\* \*Note: ECOG PS of 2 is allowed only if debilitation is caused by the gastric cancer and not by other comorbidities. * Must have normal organ and marrow function following completion of 4-6 months systemic therapy…
Interventions
- DrugCisplatin
Cisplatin interferes with DNA replication, which kills the fastest proliferating cells.
- DrugMitomycin C
A drug that slows down the growth of cancer cells by making them less able to create the DNA, RNA, and proteins they need to multiply.
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania