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.
Primary endpoints: * To assess the feasibility of recruitment * Compare complication rates between the two study arms: CRS with HIPEC and CRS alone. Secondary endpoints: * To determine risk factors for morbidity and mortality * Assess completion rate of 6 cycles of systemic chemotherapy * To determine progression free survival at 24 months * To determine overall survival at 1, 3, and 5 years * Evaluate health related quality of life Patients who meet study criteria will be randomized into one of two treatment arms: 1) cytoreductive surgery (CRS) with carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by IV combination chemotherapy with carboplatin and paclitaxel or 2) cytoreductive surgery (CRS) alone followed by adjuvant intraperitoneal (IP) and IV chemotherapy with combination cisplatin and paclitaxel for newly diagnosed advanced stage (stage III/IV) ovarian, fallopian tube or primary peritoneal cancer. Both study arms will receive 6 cycles of adjuvant chemotherapy. Twenty-four patients will undergo CRS with HIPEC performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175mg/m2) for 6 cycles postoperatively. Twenty-four patients will undergo CRS only performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by IV/IP chemotherapy with Day 1: IV paclitaxel (135 mg/m2), Day 2: IP cisplatin (75 mg/m2), and Day 8: IP paclitaxel (60 mg/m2) for 6 cycles postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Cytoreductive surgery
Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6
AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
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
Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
Mercy Medical Center
Baltimore, Maryland, United States
Post-operative complication rates
Compare post-operative complication rates between study arms
Time frame: 30 days post-operative
Assessment of quality of life
FACT-O questionnaire to assess quality of life in both study arms
Time frame: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Evaluate the rate of progression free survival
Time from intervention to disease recurrence
Time frame: at 24 months
Evaluate overall survival
Time from intervention to death
Time frame: at 1, 3, and 5 years
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