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

NCT02567253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-11-27

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wim P Ceelen, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-12-31
Completion
2021-08-25

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02567253 on ClinicalTrials.gov