At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 56 enrolled

Drug / intervention

IPEC with Cisplatin (75mg/m²) +4 moredrug

Likely dose

IPEC with Cisplatin (75mg/m²)from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02567253

NCT02567253Phase 2Completed

Compare CT.gov

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

University Hospital, Ghent·interventional·Posted Oct 2, 2015·Updated Nov 27, 2023

In Brief

A Phase 2 clinical trial evaluating Cytoreductive surgery, IPEC with Cisplatin (75mg/m²), and 3 other interventions for Ovarian Cancer and Primary Peritoneal Cancer. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOvarian Cancer, Primary Peritoneal Cancer

CountriesBelgium

Collaborators--

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedOct 2015

Enrollment StartMar 2016

Primary CompletionDec 2020

Study CompletionAug 2021

TodayJul 2026

First PostedOct 2, 2015

Enrollment StartMar 1, 2016

Primary CompletionDec 31, 2020

Study CompletionAug 25, 2021

TodayJul 2, 2026

Enrollment to primary: 4.8 yearsPosted 10.8 years ago

Interventions

Cytoreductive surgeryprocedure

Complete or nearly complete (CC-0 or CC-1) macroscopic cytoreduction at the time of surgery of peritoneal carcinomatosis from ovarian cancer

IPEC with Cisplatin (75mg/m²)drug

Intraperitoneal normotherm (37°C) administration of Cisplatin (75mg/m²) , during 90min

IPEC with Cisplatin (100mg/m²)drug

Intraperitoneal normotherm (37°C) administration of Cisplatin (100mg/m²), during 90min

Hypertherm IntraPEritoneal Chemotherapy with Cisplatin (75mg/m²)drug

Intraperitoneal hypertherm (41°C) administration of Cisplatin (75mg/m²), during 90min

HIPEC with Cisplatin (100mg/m²)drug

Intraperitoneal hypertherm (41°C) administration of Cisplatin (100mg/m²), during 90min