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NCT07733505

Overview

NCT ID: NCT07733505
Lead Sponsor: Odense University HospitalOTHER
Official Title: Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.
Brief 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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jun 16, 2026Actual
Primary Completion Date: Jan 1, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Signed informed consent.

Patient capability of giving informed consent.

Age ≥ 70 years.

Women diagnosed with epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer FIGO stage III-IV with planned interval cytoreductive surgery. Stage IV patients will only be included if they have resectable metastases within the abdominal cavity and/or abdominal wall or if they have complete remission of extra-abdominal metastases after three series of neoadjuvant chemotherapy.

Performance status 1-3.

American Society of Anaesthesiologists (ASA) scores I-III.

Normal preoperative kidney, liver and bone marrow function (according to the CTCAE v.5.0): Normal kidney function definition: eGFR or GFR ≥ 60 ml/min. Normal liver function: ALAT and/OR ASAT ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 ×ULN. Normal bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 75 × 10⁹/L; Haemoglobin level ≥ 6 mmol/L;

Completeness of cytoreduction to less than 2.5 mm.

Demographically belonging to Region of Southern Denmark.

Exclusion Criteria:

Progression of disease during NACT.

Intrabdominal metastases not resectable upon NACT.

Former history of breast cancer or other malignancies within 5 years before inclusion, except from non-melanomatous skin cancer.

Contradictions to receive carboplatin according to the SmPC (the medical oncologist makes the decision): Drug allergy (active drug or components); Severe myelosuppression; Severe kidney deficiency (creatinin clearance ≤ 30 ml/min); Bleeding tumours; Concurrent usage of vaccination against yellow fever; Severe allergic reaction to other platinum compounds in the medical history.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 10Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Lone LKP Kjeld Petersen, MD, DMScContact
lone.kjeld.petersen@rsyd.dk

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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