Trial Design
renal toxicity, gynecologic malignancies, tumor
TUMOR
This prospective, feasibility, clinical trial investigated the safety and molecular changes associated with HIPEC with cisplatin in patients with gynecologic malignancies. Initial protocol treatment did not include ST administration. However, after an interim analysis of the first 21 patients demonstrated a high rate of renal toxicity, the protocol was amended. ST was then added to the protocol for the subsequent 19 patients recruited. This study examines the effects of the protocol change in the trial.OVHIPEC-1 was referenced for the ST dosing protocol. For patients receiving ST, a bolus of 9 g/mNormal peritoneal samples were obtained at the start of surgery (pre-HIPEC) and immediately after HIPEC. Samples were primarily collected from the abdominal, pelvic, or diaphragmatic peritoneum. Other sample origins that included the omentum, appendix, and adipose tissue were considered. All normal samples were collected from locations distant from tumor. Samples were snap-frozen in liquid nitrogen and/or formalin-fixed, paraffin-embedded (FFPE) for histologic review, institutional tumor banking, and RNA extraction. Samples were stained with hematoxylin and eosin for assessment of cellularity and absence of tumor cells by a board-certified gynecologic pathologist.