Study of Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy PIPAC with Oxaliplatin in High-Risk Resected Colon Cancer Patients

What this Trial Is About

Researchers are evaluating the use of Pressurized Intraperitoneal Aerosol Chemotherapy PIPAC with oxaliplatin as an additional treatment for patients with high-risk colon cancer who have undergone surgery and, if needed, standard chemotherapy. The study aims to determine if PIPAC can reduce the chance of cancer returning in the abdomen and if it can eliminate free tumor cells present after initial treatments. This Phase 2 trial addresses a significant concern since many patients experience cancer recurrence, especially in the peritoneal area, which currently has limited treatment options. The treatment involves two PIPAC sessions delivered via laparoscopy approximately two months after surgery or right after adjuvant chemotherapy. During PIPAC, oxaliplatin is aerosolized under pressure inside the abdomen to cover the entire peritoneal surface. Each treatment lasts about 30 minutes, with a 5-week gap between the two procedures. Follow-up includes CT scans at 12, 24, and 36 months to monitor for cancer recurrence. Participants will undergo laparoscopy with peritoneal lavage and biopsies as part of the treatment process. Researchers will assess the presence of free intraperitoneal tumor cells and monitor for peritoneal cancer recurrence over three years. They will also track treatment completion rates, side effects, and overall survival outcomes. The study expects to enroll about 60 patients over two years, with ongoing observation and monitoring to evaluate the impact of PIPAC on disease progression and safety.

Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients