Clinical trial · Interventional
Normethermic Intraperitoneal Chemotherapy - a Novel Concept for Local Treatment of the Elderly and Fragile Women With Advanced Ovarian Cancer?
Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normethermic Intraperitoneal Chemotherapy with carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- NIPEC
- description
- Intraoperative Normothermic Intraperitoneal Chemotherapy with carboplatin for elderly and frail women with advanced ovarian cancer.
- interventionNames
- Drug: Normethermic Intraperitoneal Chemotherapy with carboplatin
Primary outcomes (1)
- measure
- Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions
- timeFrame
- The day that adjuvant chemotherapy starts (up to 4-6 weeks).
- description
- 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.
Secondary outcomes (20)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available