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OncoMatch/Clinical Trials/NCT07733505

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

Is NCT07733505 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies Normethermic Intraperitoneal Chemotherapy with carboplatin for ovarian cancer.

Phase 1RecruitingOdense University HospitalNCT07733505Data as of Sep 2026Location: Denmark

Treatment: Normethermic Intraperitoneal Chemotherapy with carboplatinThe 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Normethermic Intraperitoneal Chemotherapy with carboplatin

Cancer type

Ovarian Cancer

Disease stage

Required: Stage FIGO III, FIGO IV (FIGO)

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

ECOG 1–3(Limited self-care)

Demographics

Ages ≥ 70
Female only

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 75 × 10⁹/L; Haemoglobin level ≥ 6 mmol/L

Kidney function

eGFR or GFR ≥ 60 ml/min

Liver function

ALAT and/OR ASAT ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 ×ULN

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;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07733505 currently recruiting?

Yes, this trial is currently recruiting patients.

What disease stage is eligible?

Stage FIGO III or FIGO IV is required.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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