NCT02124421

HOT: HIPEC in Ovarian Cancer as Initial Treatment

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mercy Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma
• Ovarian Carcinoma
• Fallopian Tube Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Cytoreductive Surgery (CRS)	Cytoreductive surgery
DRUG	Adjuvant Chemotherapy	Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
OTHER	Questionnaire	Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
PROCEDURE	Hyperthermic intraperitoneal chemotherapy	Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6
DRUG	Carboplatin	AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
DRUG	Paclitaxel	175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
DRUG	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
DRUG	Cisplatin	Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

Timeline

• Start date: 2014-04-01
• Primary completion: 2027-08-01
• Completion: 2028-04-01
• First posted: 2014-04-28
• Last updated: 2024-11-19

Locations

1 site across 1 country: United States