Phase III Study Comparing Perioperative FLOT Chemotherapy With or Without Intraoperative HIPEC in Patients with Resectable Diffuse or Mixed Type Gastric and Gastroesophageal Junction Type IIIII Adenocarcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining perioperative FLOT chemotherapy with an intraoperative Hyperthermic IntraPEritoneal Chemoperfusion HIPEC procedure compared to FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse or mixed type adenocarcinoma of the stomach and Type IIIII gastroesophageal junction GEJ. This phase III, multicenter, randomized, open-label study focuses on patients who have received neoadjuvant FLOT therapy and do not have distant metastases, aiming to assess progression- and disease-free survival among other outcomes. Participants receive 3 to 6 cycles of biweekly neoadjuvant FLOT chemotherapy before surgery. After tumor assessment, patients without disease progression are randomized to one of two groups Arm A continues with surgery followed by four cycles of postoperative FLOT chemotherapy, while Arm B undergoes surgery combined with intraoperative HIPEC using cisplatin at 426C for 90 minutes, followed by the same postoperative FLOT cycles. Surgery typically occurs 4 to 6 weeks after the last FLOT dose, and postoperative treatment begins within 6 to 12 weeks after surgery. Throughout the study, tumor assessments using CT or MRI are performed before surgery and every three months afterward until progression, relapse, death, or study end. Clinical visits assess blood counts and toxicity before each treatment cycle. Safety monitoring includes tracking adverse and serious adverse events. Patient-reported quality of life and pain are measured regularly. The total follow-up extends up to five years to evaluate survival outcomes and relapse rates, with an initial safety phase after the first 20 patients receiving HIPEC.

HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)