HOT: HIPEC in Ovarian Cancer as Initial Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Fallopian Tube Carcinoma
- Ovarian Carcinoma
- Primary Peritoneal Carcinoma
- Stage III Ovarian Cancer
- Stage IV Ovarian Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Only males
Description
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 progres...
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.
Tracking Information
- NCT #
- NCT02124421
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Teresa Diaz-Montes, M.D. Mercy Medical Center Principal Investigator: Armando Sardi, M.D. Mercy Medical Center