NCT02567253

Intraoperative Intraperitoneal Chemoperfusion to Treat Peritoneal Minimal Residual Disease in Stage III Ovarian Cancer

Intraoperative Intraperitoneal Chemoperfusion to Treat Peritoneal Minimal Residual Disease in Stage III Ovarian Cancer: A Randomized Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The OvIP1 study is designed to examine how drug dose and perfusion temperature affect the pharmacokinetics and pharmacodynamics of cisplatin used as (hyperthermic) intraperitoneal chemoperfusion, as an adjunct to surgery, in women with stage III epithelial ovarian cancer.

Detailed description

Stage III ovarian cancer (OC) remains an important cause of cancer related mortality in women. After successful initial treatment, most patients eventually develop recurrent peritoneal disease which can only arise from peritoneal minimal residual disease (pMRD) left after primary cytoreductive surgery (CRS). Intensification of locoregional therapy through intraoperative intraperitoneal chemoperfusion (IPEC) immediately following CRS may prevent or delay peritoneal recurrence. Although IPEC, usually under hyperthermic conditions, is increasingly used in OC, its efficacy and the potential benefit of hyperthermia are at present unknown.The primary aim of this study is to assess the pharmacokinetic and pharmacodynamic properties of IP cisplatin administered under normothermic or hyperthermic conditions, and at different dosing schedules. Additional endpoints include surgery related morbidity and mortality, quality of life, overall survival, disease free survival, peritoneal recurrence free survival, peritoneal cytology, and exploration of potential biomarkers.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
PROCEDURE	Cytoreductive surgery	Complete or nearly complete (CC-0 or CC-1) macroscopic cytoreduction at the time of surgery of peritoneal carcinomatosis from ovarian cancer
DRUG	IPEC with Cisplatin (75mg/m²)	Intraperitoneal normotherm (37°C) administration of Cisplatin (75mg/m²) , during 90min
DRUG	IPEC with Cisplatin (100mg/m²)	Intraperitoneal normotherm (37°C) administration of Cisplatin (100mg/m²), during 90min
DRUG	Hypertherm IntraPEritoneal Chemotherapy with Cisplatin (75mg/m²)	Intraperitoneal hypertherm (41°C) administration of Cisplatin (75mg/m²), during 90min
DRUG	HIPEC with Cisplatin (100mg/m²)	Intraperitoneal hypertherm (41°C) administration of Cisplatin (100mg/m²), during 90min

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-31
• Completion: 2021-08-25
• First posted: 2015-10-02
• Last updated: 2023-11-27

Locations

1 site across 1 country: Belgium