Short summary

This phase two study aims to assess primarily the safety and feasibility of intraoperative normothermic chemotherapy with carboplatin after cytoreductive surgery in elderly and fragile women with advanced ovarian cancer. The secondary aims are assessing the carboplatin pharmacokinetics, and the local tissue inflammation and metabolic effects following the procedures.

Rationale

Ovarian cancer is the deadliest gynecologic cancer, often diagnosed late with peritoneal metastases, leading to a poor prognosis. Standard treatment includes cytoreductive surgery (CRS) and adjuvant chemotherapy, with hyperthermic intraperitoneal chemotherapy (HIPEC) as a new supplement targeting microscopic disease, recently added to the Danish treatment guidelines for advanced ovarian cancer. HIPEC is an intraoperative technique that uses a heated chemotherapeutic solution, often containing cisplatin. Carboplatin is a promising chemotherapeutic agent due to its favourable toxicity profile compared to cisplatin. Elderly and fragile ovarian cancer patients are currently not eligible to receive HIPEC due to pathophysiological effect of heating the abdominal cavity for 90 minutes during the operation. In general, undertreatment of this patient population is still being hypothesised and associated to inferior survival after treatment. Normothermic intraperitoneal chemotherapy (NIPEC) may be a safer alternative for elderly and fragile women with advanced ovarian cancer, minimising complications.

Description of the cohort

This study will include women ≥ 70 years old and diagnose with epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer FIGO stage III-IV admitted to planned interval cytoreductive surgery at the Department of Gynaecology and Obestetrics, Odense University Hospital.

Data and biological material

Data will consist of: - Demographics - Diagnosis - Data from the patient journal including complications and side effects to the normothermic intraperitoneal chemotherapy procedure - Questionnaire data of quality of life - Biological materials: blood samples, microdialysis samples, tissue biopsies (peritoneal and tumor tissue)

Collaborating researchers and departments

Department of Biochemistry and Immunology, Lille Baelt Sygehus

Department of Pathology, Odense University Hospital

Aarhus University

• Elisabeth Krogsgaard Petersen