Ovarian CancerPhase 1NICE-CNCT07733505
Normethermic Intraperitoneal Chemotherapy - a Novel Concept for Local Treatment of the Elderly and Fragile Women With Advanced Ovarian Cancer?
A Phase 1 study testing Normethermic Intraperitoneal Chemotherapy with carboplatin in people with Ovarian Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Normethermic Intraperitoneal Chemotherapy with carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jun 2026to 1 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Lone Kjeld Petersen LKP Kjeld Petersen, MD, DMSc, +4528968856, lone.kjeld.petersen@rsyd.dk
Elisabeth EKP Krogsgaard Petersen, MD, +4550582067, elisabethkp@clin.au.dk
About this study
Official title: Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.
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.
Read more
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
- Being tested
- Normethermic Intraperitoneal Chemotherapy with carboplatin
- Keywords
- Ovarian cancer, Normothermic Intraperitoneal Chemotherapy, NIPEC, Elderly and frail patients, Intraperitoneal tissue pharmacokinetics, Intraperitoneal tissue responses
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normethermic Intraperitoneal Chemotherapy with carboplatinDrug
Also called NIPEC with carboplatin
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℃.
| Study group | Role | What they receive |
|---|---|---|
| NIPEC | Other | Intraoperative Normothermic Intraperitoneal Chemotherapy with carboplatin for elderly and frail women with advanced ovarian cancer. Receives: Drug: Normethermic Intraperitoneal Chemotherapy with carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
Secondary outcomes (20)
Length of hospital stay
Amount of days that the participant stays at the hospital following cytoreductive surgery and NIPEC.
Measured: The day of hospital discharge (up to 14 days).
Proportion of reoperations
Proportion of patients going through abdominal/gynecological reoperation and cause.
Measured: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
Proportion of readmissions.
Proportion of patients being readmitted to the hospital and cause.
Measured: 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.
Measured: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
Completion of adjuvant chemotherapy.
Proportion of participants completing the adjuvant chemotherapy.
Measured: 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.
Measured: At study completion (at 6 months)
Patient reported adverse events
Patient reported outcomes on adverse events assessed by PRO-CTCAE.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 360 min. post-dose
Carboplatin Tmax in peritoneum parietale
Time to carboplatin maximum concentration (Tmax) in peritoneum parietale measured using microdialysis.
Measured: Up to 360 min. post-dose
Carboplatin T½ in peritoneum parietale
Carboplatin half-life (T½) in peritoneum parietale measured using microdialysis.
Measured: Up to 360 min. post-dose
Carboplatin AUC in tumor tissue
Carboplatin Area Under the Plasma Concentration Versus Time Curve in peritoneal tumor tissue measured using microdialysis.
Measured: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose
Carboplatin Cmax in tumor tissue
Time to carboplatin maximum concentration (Cmax) in tumor tissue measured using microdialysis.
Measured: Up to 360 min. post-dose
Carboplatin Tmax in tumor tissue
Time to carboplatin maximum concentration (Tmax) in tumor tissue measured using microdialysis.
Measured: Up to 360 min. post-dose
Carboplatin T½ in tumor tissue
Carboplatin half-life (T½) in tumor tissue measured using microdialysis.
Measured: Up to 360 min. post-dose
Change in inflammatory response in parietal peritoneum
Inflammatory response will be assessed in peritoneal tissue samples using histopathological and/or molecular markers. Changes associated with intraperitoneal chemotherapy will be evaluated.
Measured: Baseline (before NIPEC) and up to 15 min. post-NIPEC
Change in inflammatory response in tumor tissue
Inflammatory response will be assessed in tumor tissue samples using histopathological and/or molecular markers. Changes associated with intraperitoneal chemotherapy will be evaluated.
Measured: Baseline (before NIPEC) and up to 15 min. post-NIPEC
Inflammatory protein changes in parietal peritoneum
Changes in inflammatory protein levels in parietal peritoneum during NIPEC and up to 6 hours post-NIPEC will be measured using microdialysis.
Measured: 90 min and 360 min after NIPEC initiation (post-dose).
Ichemic metabolites changes in parietal peritoneum
Changes in ischemic metabolites (lactate, pyruvate, glucose and glycerol) levels in parietal peritoneum during NIPEC and up to 6 hours post-NIPEC will be measured using microdialysis.
Measured: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. after NIPEC initiation (post-dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start16 Jun 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733505
- Sponsor's protocol ID
- 26/12528
- Other IDs
- 2025-522269-30-00, 2025
- Acronym
- NICE-C
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and supporting information may be shared upon reasonable request following publication of the primary results, subject to approval by the sponsor and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT07733505
- Acronym / sponsor ID
- NICE-C / 26/12528
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Normothermic Intraperitoneal Chemotherapy, NIPEC, Elderly and frail patients, Intraperitoneal tissue pharmacokinetics, Intraperitoneal tissue responses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIPEC | Other | Drug: Normethermic Intraperitoneal Chemotherapy with carboplatinIntraoperative Normothermic Intraperitoneal Chemotherapy with carboplatin for elderly and frail women with advanced ovarian cancer. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normethermic Intraperitoneal Chemotherapy with carboplatinAlso: NIPEC with carboplatinNormothermic Intraperitoneal Chemotherapy is being performed intraoperatively with carboplatin 800mg/m^2 for 90 min intraperitoneal circulation at normal body temperature 36.5-37.5℃. | Drug | NIPEC |
Primary outcome
Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions
Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
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.
20 secondary outcomes
Length of hospital stay
Time frame: The day of hospital discharge (up to 14 days).
Proportion of reoperations
Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
Proportion of readmissions.
Time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
Time from surgery 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.
Time frame: At second follow up (3 months).
Patients' willingness to participate.
Time frame: At study completion (at 6 months)
Patient reported adverse events
Time frame: At first follow up (up to 6 weeks).
Change in health-related quality of life using EORCT-questionnaires
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
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose
Carboplatin Cmax in peritoneum parietale
Time frame: Up to 360 min. post-dose
Carboplatin Tmax in peritoneum parietale
Time frame: Up to 360 min. post-dose
Carboplatin T½ in peritoneum parietale
Time frame: Up to 360 min. post-dose
Carboplatin AUC in tumor tissue
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose
Carboplatin Cmax in tumor tissue
Time frame: Up to 360 min. post-dose
Carboplatin Tmax in tumor tissue
Time frame: Up to 360 min. post-dose
Carboplatin T½ in tumor tissue
Time frame: Up to 360 min. post-dose
Change in inflammatory response in parietal peritoneum
Time frame: Baseline (before NIPEC) and up to 15 min. post-NIPEC
Change in inflammatory response in tumor tissue
Time frame: Baseline (before NIPEC) and up to 15 min. post-NIPEC
Inflammatory protein changes in parietal peritoneum
Time frame: 90 min and 360 min after NIPEC initiation (post-dose).
Ichemic metabolites changes in parietal peritoneum
Time frame: 30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. after NIPEC initiation (post-dose).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and supporting information may be shared upon reasonable request following publication of the primary results, subject to approval by the sponsor and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Normethermic Intraperitoneal Chemotherapy with carboplatin in people with Ovarian Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lone LKP Kjeld Petersen, MD, DMSc (+4528968856, lone.kjeld.petersen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions (time frame: The day that adjuvant chemotherapy starts (up to 4-6 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.