Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
10
Countries
1
Sites
1
Ovarian cancer
This study aims to assess Normothermic Intraperitoneal Chemotherapy’s (NIPEC) safety, feasibility, pharmacokinetics, and its impact on local tissue inflammation and ischemia. NIPEC could offer an alternative treatment for elderly ovarian cancer patients ineligible for Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 7 Apr 2026 → ongoing
- Decision date (initial)
- 2025-12-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety
This study aims to assess Normothermic Intraperitoneal Chemotherapy’s (NIPEC) safety, feasibility, pharmacokinetics, and its impact on local tissue inflammation and ischemia. NIPEC could offer an alternative treatment for elderly ovarian cancer patients ineligible for Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
Secondary objectives 1
- This study can bridge a new porcine model to older and fragile women with advanced OC with peritoneal metastasis. Bridging findings from the porcine model to a clinical setup will provide valuable translational insights.
Conditions and MedDRA coding
Ovarian cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- 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.
- Completeness of cytoreduction to less than 2.5 mm.
- Demographically belonging to Region of Southern Denmark.
Exclusion criteria 4
- Progression of disease during neoadjuvant chemotherapy.
- 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 receiving carboplatin, such as drug allergy. The medical oncologist makes the decision.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 10
- Length of hospital stay.
- Proportion of reoperations and cause.
- Proportion of readmissions and cause.
- Time from surgery to the first dose of adjuvant systemic chemotherapy.
- Proportion of participants completing the adjuvant chemotherapy of three cycles.
- Feasibility according to patients willing to participate in the trial.
- PROs on QoL assessed by questionnaires.
- Costs of NIPEC in addition to standard treatment.
- Carboplatin local peritoneal tissue and systemic plasma pharmacokinetics measured using microdialysis.
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 800 mg/m2 milligram(s)/sq. meter
- Max total dose
- 800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The administrative form is intraperitoneal
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J. B. Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Lone Kjeld Petersen
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Lone Kjeld Petersen
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Sygehus Lillebaelt Vejle Sygehus ORG-100031262
|
Vejle, Denmark | Laboratory analysis |
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-04-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522269-30-00 | 2 |
| Protocol (for publication) | D1_Protocol_2025-522269-30-00_v3 | 3 |
| Protocol (for publication) | D2_other subject information materia_questionnarie EORCT QLQ-C30_da | 1 |
| Protocol (for publication) | D3_other subject information materia_questionnarie EORCT QLQ-OV28_da | 1 |
| Protocol (for publication) | D4_other subject information materia_questionnarie EORCT QLQ_CR29_da | 1 |
| Protocol (for publication) | D5_other subject information materia_questionnarie PRO-CTCAE_da | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_v2_changes marked with red | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_letter to the patient after MDT | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_letter to the patient after MDT_v3 - with track changes | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_v2_with track-changes | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_v3 with track changes | 1 |
| Subject information and informed consent form (for publication) | L2_Dine rettigheder som forsgsperson i forsg med medicin _ De Videnskabsetiske Komiteer | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC 1_Carboplatin_2025-522269-30-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-19 | Denmark | Acceptable 2025-12-02
|
2025-12-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-07 | Denmark | Acceptable 2025-12-02
|
2026-04-07 |