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HOT: HIPEC in Ovarian Cancer as Initial Treatment — CRS/HIPEC  

Fallopian Tube Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02124421
Study type Interventional
Source Mercy Medical Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 2014
Completion date April 2028
View Details
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