NCT07733505RecruitingPhase 1
Normethermic Intraperitoneal Chemotherapy - a Novel Concept for Local Treatment of the Elderly and Fragile Women With Advanced Ovarian Cancer?
Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 16 Jun 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Odense University Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT07733505
- EU CT number
- 2025-522269-30-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 16 Jun 2026 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Progression of disease during NACT.
- Former history of breast cancer or other malignancies within 5 years before inclusion, except from non-melanomatous skin cancer.
Lab values
- 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.
Other
- Intrabdominal metastases not resectable upon NACT.
Who the study is looking for
- 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.
Age in the registry: 70 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.