NCT07733505 Normethermic Intraperitoneal Chemotherapy - a Novel Concept for Local Treatment of the Elderly and Fragile Women With Advanced Ovarian Cancer?
| NCT ID | NCT07733505 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Odense University Hospital |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-06-16 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-06-16 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07733505 clinical trial?
This trial is open to female participants only, aged 70 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07733505 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07733505 currently recruiting?
Yes, NCT07733505 is actively recruiting participants. Contact the research team at lone.kjeld.petersen@rsyd.dk for enrollment information.
Where is the NCT07733505 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT07733505 clinical trial?
NCT07733505 is sponsored by Odense University Hospital. The trial plans to enroll 10 participants.
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