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Normethermic Intraperitoneal Chemotherapy - a Novel Concept for Local Treatment of the Elderly and Fragile Women With Advanced Ovarian Cancer?

NCT07733505 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-29

No results posted yet for this study

Summary

The purpose of this feasibility study is to investigate whether NIPEC with carboplatin after surgery is safe for the elderly and frail women with advanced ovarian cancer.

To achieve this, women with advanced ovarian cancer who receive surgery followed by NIPEC will be closely monitored in the period after treatment. We will assess complications, side effects, recovery after surgery and NIPEC, and whether standard chemotherapy can be started on time and completed as planned.

In addition, participants will be followed for six months using questionnaires and interviews to evaluate patient-reported outcomes, including quality of life.

In the more technical assessment of NIPEC, carboplatin tissue pharmacokinetics and inflammatory responses during and after NIPEC will be analysed using microdialysis and histology.

Conditions

Interventions

DRUG

Normethermic Intraperitoneal Chemotherapy with carboplatin

Normothermic Intraperitoneal Chemotherapy is being performed intraoperatively with carboplatin 800mg/m\^2 for 90 min intraperitoneal circulation at normal body temperature 36.5-37.5℃.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-16
Primary Completion
2028-01-01
Completion
2028-05-01

Countries

  • Denmark

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 NCT07733505 on ClinicalTrials.gov