Carboplatin for Epithelial ovarian cancer | Fallopian tube cancer | Primary peritoneal cancer

Inclusion criteria

• {"criterion_text":"- Signed informed consent."}
• {"criterion_text":"- Patient capability of giving informed consent."}
• {"criterion_text":"- Age ≥ 70 years."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Performance status 1-3."}
• {"criterion_text":"- American Society of Anaesthesiologists (ASA) scores I-III."}
• {"criterion_text":"- Normal preoperative kidney, liver and bone marrow function."}
• {"criterion_text":"- Completeness of cytoreduction to less than 2.5 mm."}
• {"criterion_text":"- Demographically belonging to Region of Southern Denmark."}

Exclusion criteria

• {"criterion_text":"- Progression of disease during neoadjuvant chemotherapy."}
• {"criterion_text":"- Intrabdominal metastases not resectable upon NACT."}
• {"criterion_text":"- Former history of breast cancer or other malignancies within 5 years before inclusion, except from non-melanomatous skin cancer."}
• {"criterion_text":"- Contradictions to receiving carboplatin, such as drug allergy. The medical oncologist makes the decision."}

Primary endpoints

• {"endpoint_text":"- Safety of the treatment of cytoreductive surgery combined with Normothermic Intraperitoneal Chemotherapy with carboplatin: The proportions of patients 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.","definition_or_measurement_approach":"Proportions of patients experiencing perioperative and postoperative complications/AEs of grade 3-5 as per CTCAE v5.0 and Clavien-Dindo classification; ADRs related to carboplatin assessed until the day of adjuvant chemotherapy start."}

Secondary endpoints

• {"endpoint_text":"- Length of hospital stay.","definition_or_measurement_approach":"Measured as duration of inpatient stay (days)."}
• {"endpoint_text":"- Proportion of reoperations and cause.","definition_or_measurement_approach":"Proportion of participants requiring reoperation and documented causes."}
• {"endpoint_text":"- Proportion of readmissions and cause.","definition_or_measurement_approach":"Proportion of participants readmitted after discharge and documented causes."}
• {"endpoint_text":"- Time from surgery to the first dose of adjuvant systemic chemotherapy.","definition_or_measurement_approach":"Measured in days from date of surgery to date of first adjuvant systemic chemotherapy administration."}
• {"endpoint_text":"- Proportion of participants completing the adjuvant chemotherapy of three cycles.","definition_or_measurement_approach":"Proportion completing three cycles of adjuvant chemotherapy."}
• {"endpoint_text":"- Feasibility according to patients willing to participate in the trial.","definition_or_measurement_approach":"Assessed by recruitment and consent rates (willingness to participate)."}
• {"endpoint_text":"- PROs on QoL assessed by questionnaires.","definition_or_measurement_approach":"Patient-reported outcomes on quality of life assessed by questionnaires (EORTC QLQ-C30 and disease-specific modules referenced in documents)."}
• {"endpoint_text":"- Costs of NIPEC in addition to standard treatment.","definition_or_measurement_approach":"Health economic assessment of incremental costs of NIPEC plus standard treatment."}
• {"endpoint_text":"- Carboplatin local peritoneal tissue and systemic plasma pharmacokinetics measured using microdialysis.","definition_or_measurement_approach":"Pharmacokinetic measurements from microdialysis samples and plasma to determine local peritoneal tissue and systemic carboplatin levels."}
• {"endpoint_text":"- Local peritoneal tissue and systemic response using inflammation protein markers, ischemic metabolites and histology. The local response will be assessed in both macroscopic healthy peritoneal tissue and tumour nodules less than 1 cm.","definition_or_measurement_approach":"Assessment of inflammatory protein markers, ischemic metabolites and histology in peritoneal tissue and tumour nodules (<1 cm) and systemic response measures."}

Denmark

Earliest CTIS Part Ii Submission Date

15-12-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Sygehus Lillebaelt Vejle Sygehus","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: [\"1\",\"8\"]","organisation_type":"Hospital/Clinic/Other health care facility"}