Normothermic Intraperitoneal Chemotherapy after surgery for elderly and frail women with advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 feasibility study investigates the safety of normothermic intraperitoneal carboplatin given after tumor debulking surgery in women aged 70 and older with advanced ovarian cancer. Participants are closely monitored for surgical and NIPEC-related complications, recovery timelines, and whether standard systemic chemotherapy can be started on schedule. The study also collects patient-reported outcomes, including quality of life, over six months. Technical assessments include tissue pharmacokinetics and inflammatory responses measured by microdialysis and histology. The trial will inform future work on feasibility and potential benefits of NIPEC in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Study coordinator: Lone LKP Kjeld Petersen, MD, DMSc
• Email: lone.kjeld.petersen@rsyd.dk
• Phone: +4528968856

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.