This phase II trial tests whether secondary cytoreductive surgery and hyperthemic intraperitoneal cisplatin works to shrink tumors in patients with mucinous ovarian cancer that has come back (recurrent). Cytoreductive surgery is an operation to remove as much tumor tissue as possible. Hyperthermic intraperitoneal chemotherapy is a type of treatment delivery method where the chemotherapy is given directly into the abdominal cavity. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing , stopping or slowing the growth of cancer cells. This trial aims to see whether hyperthemic intraperitoneal cisplatin given during cytoreductive may help to control ovarian cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05123807.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Aaron Shafer
Phone: 832-885-6133
PRIMARY OBJECTIVE:
I. To estimate progression-free survival (PFS) after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for women with recurrent primary mucinous ovarian cancer.
SECONDARY OBJECTIVES:
I. To estimate overall survival (OS) after cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer.
II. To evaluate toxicity and morbidity of cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer.
III. To estimate quality of life after cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer.
IV. To estimate what proportion of patients who preoperatively appear to be candidates for cytoreductive surgery and HIPEC are found to have unresectable disease at time of surgical exploration.
V. To collect blood and tumor samples for biobanking to be used for exploratory endpoints.
OUTLINE:
Patients undergo cytoreductive surgery and receive cisplatin via intraoperative hyperthermic perfusion over 60 minutes.
After completion of study treatment, patients are followed up for 30 days, and then at 3, 6, 9, 12, 16, 20, and 24 months, then every 6 months for up to 72 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAaron Shafer