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

Sponsor
Odense University Hospital
Study ID
NCT07733505
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Normethermic Intraperitoneal Chemotherapy with carboplatin — DRUG
    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℃.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Jun 16, 2026
Status verified
Jul 2026
Primary completion
Jan 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: NIPEC
    Intraoperative Normothermic Intraperitoneal Chemotherapy with carboplatin for elderly and frail women with advanced ovarian cancer.

Primary Outcome Measure

Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions [ Time Frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks). ]

Central Contacts

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