Stage IV Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial Comparing Quality of Life After HIPEC in Patients With Stage IIIC and IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
This phase II trial studies how well hyperthermic intraperitoneal chemotherapy works in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill any cancer cells left over after surgery.
PRIMARY OBJECTIVES: I. To compare quality of life in patients with advanced ovarian cancer treated with standard of care (SOC) neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) at 6 weeks post-treatment versus quality of life (QOL) patients treatment with intravenous-therapy (IV) chemotherapy. SECONDARY OBJECTIVES: I. To describe quality of life in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC at 3 and 6 months post-treatment. II. To describe neurotoxicity in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. III. To describe abdominal discomfort in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. IV. To describe toxicities in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. V. To describe the response rate in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. VI. To describe progression-free survival (PFS) in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. OUTLINE: Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin intraperitoneally (IP) over 90 minutes immediately following CRS. After completion of chemotherapy, patients are followed up at 30 days, and 3, 6, and 12 months. ;
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