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

NCT07733505 | Recruiting Phase 1

• 2 other identifiers: 26/125282025-522269-30-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer

Keywords

Ovarian cancer; Normothermic Intraperitoneal Chemotherapy; NIPEC; Elderly and frail patients; Intraperitoneal tissue pharmacokinetics; Intraperitoneal tissue responses

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (20)

• Length of hospital stay

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

• Proportion of reoperations

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

• Proportion of readmissions.

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

• Time from surgery to the first dose of adjuvant systemic chemotherapy.

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

• Completion of adjuvant chemotherapy.

  At second follow up (3 months).

Study Arms (1)

NIPEC

OTHER

Intraoperative Normothermic Intraperitoneal Chemotherapy with carboplatin for elderly and frail women with advanced ovarian cancer.

Drug: Normethermic Intraperitoneal Chemotherapy with carboplatin

Interventions

Normethermic Intraperitoneal Chemotherapy with carboplatin DRUG

Normothermic Intraperitoneal Chemotherapy is being performed intraoperatively with carboplatin 800mg/m\^2 for 90 min intraperitoneal circulation at normal body temperature 36.5-37.5℃.

Also known as: NIPEC with carboplatin

NIPEC

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Progression of disease during NACT.
• Intrabdominal metastases not resectable upon NACT.
• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Lone LKP Kjeld Petersen, MD, DMSc

CONTACT

+4528968856; lone.kjeld.petersen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 29, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol and ICF is available at https://euclinicaltrials.eu/ from December 2025 with no end date. The SAP will be available from June 16 2026 with no end date. The IPD is available from the day of publication of the results, with no end date.
• Access Criteria: De-identified individual participant data underlying the reported study results, as well as the above stated supporting information, may be made available to qualified healthcare professionals and researchers upon reasonable request. Requests for access should be submitted to the study sponsor/investigator and will be reviewed on a case-by-case basis. Access may be granted subject to applicable ethical approvals, data protection regulations, and data sharing agreements. Data will not be made publicly available.

Locations

DK (1)