Spots Global Cancer Trial Database for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor
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Trial Identification
Brief Title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor
Official Title: Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase I-II Clinical Trial
Study ID: NCT02735928
Study Description
Brief Summary: Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.
Detailed Description: This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and doxorubicin in women with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Catholic University of Sacred Heart, Rome, , Italy
Contact Details
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