Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients
NCT03321188 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-02-06
Summary
This study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV) chemotherapy can be started within 42 days of HIPEC and cytoreduction. All patients will receive cytoreductive surgery followed by a one-time closed HIPEC with cisplatin at 41-43 degrees Celsius for 90 minutes in the operating room. This is followed by 6 cycles of intravenous carboplatin and paclitaxel on an outpatient basis.
Conditions
- Ovarian Cancer
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
Interventions
- PROCEDURE
-
HIPEC
HIPEC with cisplatin
- DRUG
-
Adjuvant IV chemotherapy
- DRUG
-
Adjuvant IV chemotherapy
Sponsors & Collaborators
-
University of Kansas Medical Center
collaborator OTHER -
Andrea Jewell
lead OTHER
Principal Investigators
-
Andrea Jewell, MD · The University of Kansas - Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-15
- Primary Completion
- 2023-12-15
- Completion
- 2024-12-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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