Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2024
Patients will be registered prior to, during or at the completion of neoadjuvantchemotherapy given per standard institutional guidelines +/‐ bevacizumab on Day 1 every21 days for 3‐4 cycles. Registered patients who progress during neoadjuvant chemotherapywill not be eligible for iCRS and will be removed from the study.Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS)will be performed in the usual fashion in both arms. Patients will be randomized at thetime of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm inlargest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm willreceive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. Afterpostoperative recovery patients will receive standard post‐operative platinum‐basedcombination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receivepostoperative standard chemotherapy after recovery from surgery.Both groups will receive an additional 2‐3 cycles of platinum‐based combinationchemotherapy per standard institutional guidelines +/‐ bevacizumab for a maximum total of6 cycles of chemotherapy (neoadjuvant plus post‐operative cycles) followed by niraparibindividualized dosing +/‐ bevacizumab until progression or 36 months (if no evidence ofdisease).
Epistemonikos ID: 844e03443ff4201c4b657292a0d0de5e31cd8bb8
First added on: May 14, 2024