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

Официальное название

Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.

Обзор

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.

Вмешательства

• Препарат Normethermic Intraperitoneal Chemotherapy with carboplatin
  Normothermic Intraperitoneal Chemotherapy is being performed intraoperatively with carboplatin 800mg/m\^2 for 90 min intraperitoneal circulation at normal body temperature 36.5-37.5℃.

Первичные конечные точки

• Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions [Срок оценки: The day that adjuvant chemotherapy starts (up to 4-6 weeks).]

Вторичные конечные точки (12)

• Length of hospital stay [Срок оценки: The day of hospital discharge (up to 14 days).]
• Proportion of reoperations [Срок оценки: The day that adjuvant chemotherapy starts (up to 4-6 weeks).]
• Proportion of readmissions. [Срок оценки: The day that adjuvant chemotherapy starts (up to 4-6 weeks).]
• Time from surgery to the first dose of adjuvant systemic chemotherapy. [Срок оценки: The day that adjuvant chemotherapy starts (up to 4-6 weeks).]
• Completion of adjuvant chemotherapy. [Срок оценки: At second follow up (3 months).]
• Patients' willingness to participate. [Срок оценки: At study completion (at 6 months)]
• Patient reported adverse events [Срок оценки: At first follow up (up to 6 weeks).]
• Change in health-related quality of life using EORCT-questionnaires [Срок оценки: Baseline, follow-up 1 (up to 6 weeks), follow-up 2 (3 months) and follow-up 3 (6 months).]
• Carboplatin AUC in peritoneum parietale [Срок оценки: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose]
• Carboplatin Cmax in peritoneum parietale [Срок оценки: Up to 360 min. post-dose]
• Carboplatin Tmax in peritoneum parietale [Срок оценки: Up to 360 min. post-dose]
• Carboplatin T½ in peritoneum parietale [Срок оценки: Up to 360 min. post-dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Odense University Hospital — Odense

Идентификаторы

NCT: NCT07733505 · 26/12528 · 2025-522269-30-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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