HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma

NCT02487849 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-03-04

No results posted yet for this study

Summary

The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian carcinoma. Condition for HIPEC is attainment of optimal cytoreduction (R0) and experts judgement of a complication-free prolongation of narcosis after finishing the surgery. HIPEC will be administered additionally to standard therapy. If HIPEC was executed the number of systemic given platinum-based chemotherapy decreases for one cycle.

This regime should be investigated in terms of safety of performance, quality of life for the patients and consequences for the following systemic chemotherapy.

Conditions

Interventions

PROCEDURE

HIPEC

secondary cytoreductive operation

DRUG

Carboplatin

Hyperthermal Intraperitoneal Chemotherapy (HIPEC)

Sponsors & Collaborators

  • Krankenhaus Barmherzige Schwestern Linz

    lead OTHER

Principal Investigators

  • Lukas Hefler, Prim. Dr. · Krankenhaus der Barmherzigen Schwestern Linz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Austria

Study Locations

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Entities

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 NCT02487849 on ClinicalTrials.gov