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10 active trials for Stage IV Ovarian Cancer

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer

Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks). The primary objective of the study is to determine the maximum tolerated dose (MDT). During cycle 1, limiting dose toxicity must be collected in real time. Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1. The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial. Secondary objectives are : to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy to describe the pharmacokinetic of the PIPAC chemotherapy to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous). At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized.. In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.

Pierre-BéniteStart: July 2021
18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer (PET HOC)

The purpose of this study is to determine whether high grade epithelial ovarian cancers (=HG EOC) are 18F-DCFPyL (=2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid)-avid and to compare the performance of this PET to CT and findings at time of surgery Background: There is a need for better noninvasive tools that will map disease extent in HG EOC. A recent study has shown that at immunohistochemistry GCP=II is overexpressed in ovarian cancer tumors, both primary and metastatic. Glucose carboxypeptidase-II (=GCP-II), also known as prostate specific membrane antigen (= PSMA) has been used clinically to assess patients with prostate cancer and many other tumors have been shown to be PSMA-avid on PET (including renal cell carcinomas). 18F-DCFPyL has the potential to improve patient selection for primary therapy. If successful, this may decrease the rate of futile surgeries and associated morbidity and better direct patients to the most appropriate therapy primary debulking surgery (PDS) vs neoadjuvant chemotherapy (NACT). Furthermore, if high-level GCP-II expression is shown at preoperative imaging in patients with HG EOC, this may be used in considering feasibility of future theranostic applications. Study Design: This is a single arm pilot study to assess whether HG EOC are 18F-DCFPyL-avid. In this prospective trial, the investigators will recruit 20 women whom will undergo conventional staging with contrast-enhanced CT of the abdomen and pelvis as per standard of care. All disease sites, primary and metastatic will be recorded using a standardized reporting template. Subsequently, 18F-DCFPyL-PET/CT will be performed (within 6 weeks of CT). All disease sites on PET will be recorded using same reporting template in addition to qualitative and semiquantitative evaluation (SUV measurement) of all known tumor sites.

Toronto, OntarioStart: April 2019