At a glance
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A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
In Brief
A Phase 2 clinical trial evaluating Second look laparoscopy reassessment surgery (SLLRS), HIPEC with Carboplatin, and 1 other intervention for Ovarian Epithelial Cancer Stage I and 6 related conditions. Completed, enrolled 10 participants across 1 site.
Signals
Detailed Summary
The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.
Study Details
Timeline
Arms & Interventions
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Interventions
Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes. Patients who exhibit the following will not receive the HIPEC procedure: * Extraperitoneal disease noted at the time of the second look procedure * Macroscopic intraperitoneal disease which is not resectable to R1 * Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion * Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.