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

Phase 1RecruitingNCT07733505

Odense University Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).

Secondary Outcomes

Length of hospital stay

Amount of days that the participant stays at the hospital following cytoreductive surgery and NIPEC.

Time frame: The day of hospital discharge (up to 14 days).

Proportion of reoperations

Proportion of patients going through abdominal/gynecological reoperation and cause.

Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).

Proportion of readmissions.

Proportion of patients being readmitted to the hospital and cause.

Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).

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.

Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).

Completion of adjuvant chemotherapy.

Proportion of participants completing the adjuvant chemotherapy.

Time frame: At second follow up (3 months).

Patients' willingness to participate.

Proportion of patients who are asked to participate in the study who provide written informed consent.

Time frame: At study completion (at 6 months)

Patient reported adverse events

Patient reported outcomes on adverse events assessed by PRO-CTCAE.

Time frame: At first follow up (up to 6 weeks).

Change in health-related quality of life using EORCT-questionnaires

Quality of Life (QoL), assessed using the EORTC QLQ-C30 and the disease-specific modules EORTC QLQ-OV28 and EORTC QLQ-CR29, will be measured at baseline and at follow-up 1, 2, and 3. Changes in QoL scores over time will be evaluated by comparing questionnaire scores across the assessment time points.

Time frame: Baseline, follow-up 1 (up to 6 weeks), follow-up 2 (3 months) and follow-up 3 (6 months).

Carboplatin AUC in peritoneum parietale

Carboplatin Area Under the Plasma Concentration Versus Time Curve in peritoneum parietale measured using microdialysis.

Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose

Carboplatin Cmax in peritoneum parietale

Carboplatin maximum concentration in peritoneum parietale measured using microdialysis.