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Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward: a Multicenter, Prospective, Feasibility Study (GARD-HIPEC Study)
Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion.
The Dutch Model is limited for the following reasons: 1) The HIPEC treatment requires to be done in the operating room, which means the operation time would be lengthened. 2) High rate of exposure to chemotherapeutic drugs among healthcare workers. 3) It has significant safety concerns because it does not take into account racial differences in drug toxicity. This study is an investigator-initiated prospective multicenter feasibility study with a non-inferiority design, so as to provide evidence-based medical evidence for the use of the C-HIPEC model as an alternative to the "Dutch model" in clinical practice in China.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
Start Date
February 1, 2024
Primary Completion Date
December 1, 2024
Completion Date
May 1, 2025
Last Updated
February 26, 2024
92
ESTIMATED participants
China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC)
PROCEDURE
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
NCT07432633
NCT05867251
Data Source & Attribution
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