Phase I Study Evaluating Safety of Cisplatin with Heated Chemotherapy During or Before Surgery for Advanced Stage IIIIV Ovarian, Fallopian Tube, or Peritoneal Cancer Receiving Neoadjuvant Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and tolerability of two different approaches using cisplatin chemotherapy in patients with stage III or IV ovarian, fallopian tube, or peritoneal cancer who receive chemotherapy before surgery. This phase I trial compares giving cisplatin intravenously the day before surgery versus using heated cisplatin chemotherapy infused into the abdominal cavity during surgery. The study also looks at treatment feasibility, delays, patient quality of life, cancer recurrence, survival, and changes in gut bacteria. Participants receive carboplatin and paclitaxel intravenously every three weeks for 3 to 4 cycles. After these cycles, patients who respond to treatment undergo interval cytoreductive surgery. Then, they are randomly assigned to one of two groups one group receives intravenous cisplatin the day before surgery, and the other group receives heated cisplatin chemotherapy HIPEC during surgery. Throughout the trial, stool samples and diagnostic imaging are collected to monitor treatment effects. During the study, participants complete quality-of-life questionnaires and provide stool samples at various times. Researchers assess chemotherapy-related side effects within 30 days after treatment, monitor treatment feasibility, and follow patients for up to 30 days after treatment completion. Longer-term outcomes like recurrence-free survival and overall survival are tracked for several years, along with changes in the gut microbiome and tumor response. The total duration of participation varies based on treatment and follow-up schedules.

Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer