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
NCT05415709 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-02-11
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.
Conditions
- Fallopian Tube Endometrioid Adenocarcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Fallopian Tube Serous Adenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Mucinous Adenocarcinoma
- Ovarian Serous Adenocarcinoma
- Primary Peritoneal Endometrioid Adenocarcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Stage III Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- PROCEDURE
-
Cytoreductive Surgery
Undergo CRS
- DRUG
-
Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
- DRUG
-
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
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Floor Backes, MD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-13
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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