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Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer
Sponsor: Ohio State University Comprehensive Cancer Center
Summary
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.
Official title: Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2022-06-13
Completion Date
2026-12-31
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Carboplatin
Given IV
Cisplatin
Given IV
Cytoreductive Surgery
Undergo CRS
Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Paclitaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Biospecimen Collection
Undergo stool sample collection
Diagnostic Imaging
Undergo diagnostic imaging
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States