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HOT: HIPEC in Ovarian Cancer as Initial Treatment
Sponsor: Mercy Medical Center
Summary
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Official title: Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2014-04
Completion Date
2028-04
Last Updated
2024-11-19
Healthy Volunteers
No
Conditions
Interventions
Cytoreductive Surgery (CRS)
Cytoreductive surgery
Adjuvant Chemotherapy
Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
Questionnaire
Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
Hyperthermic intraperitoneal chemotherapy
Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6
Carboplatin
AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
Paclitaxel
175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
Paclitaxel
Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
Cisplatin
Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
Locations (1)
Mercy Medical Center
Baltimore, Maryland, United States