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

Official record

Identifier

NCT07733505

Recruiting locations

country

Denmark

Interventions studied

Normethermic Intraperitoneal Chemotherapy with carboplatin

Lead sponsor

Odense University Hospital

Target enrolment

10 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Jul 29, 2026

Last updated on the registry

Jul 29, 2026

Age

70 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.