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.
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.
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.
Single group
Normethermic Intraperitoneal Chemotherapy with carboplatin
DrugNormothermic Intraperitoneal Chemotherapy is being performed intraoperatively with carboplatin 800mg/m\^2 for 90 min intraperitoneal circulation at normal body temperature 36.5-37.5℃.
Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions
The proportions of participants experiencing perioperative and postoperative complications of adverse events (AEs) of grade 3 to 5 according to the Common Terminology for Adverse Events (CTCAE) version 5.0 and Clavien-Dindo classification (surgical AEs) together with adverse drug reactions (ADRs) related to carboplatin until the day of adjuvant chemotherapy start.
Length of hospital stay
Amount of days that the participant stays at the hospital following cytoreductive surgery and NIPEC.
Proportion of reoperations
Proportion of patients going through abdominal/gynecological reoperation and cause.
Proportion of readmissions.
Proportion of patients being readmitted to the hospital and cause.
Time from surgery to the first dose of adjuvant systemic chemotherapy.
The amount of days from the say of surgery and NIPEC to the first dose of adjuvant systemic chemotherapy.
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Odense University Hospital
Lead sponsor
University of Aarhus
Collaborator
