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RECRUITING
NCT05415709
EARLY_PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Cytoreductive Surgery

Undergo CRS

DRUG

Hyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC

DRUG

Paclitaxel

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Biospecimen Collection

Undergo stool sample collection

PROCEDURE

Diagnostic Imaging

Undergo diagnostic imaging

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States