Ovarian CancerNACT-KELIM IDNCT07382479
NeoAdjuvant ChemoTherapy With KELIM Guided Interval vs. Delayed Interval Debulking Surgery
A study testing 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS and 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT in people with Ovarian Cancer, run by Aristotle University Of Thessaloniki.
Trial summary
A prospective, international, multi-center, interventional trial of advanced epithelial ovarian cancer patients offered three cycles of neoadjuvant chemotherapy (NACT) and triaged with KELIM score. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS and 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2034
- Phase
- Interventional
- 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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 85 years old
- Histologically proven epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, high grade serous or endometrioid
- ECOG Performance status 0 - 1
- Documented International Federation of Gynecologic Oncology (FIGO) 2014 stage IIIB, IIIC or IVA unfit and/or with unresectable disease for complete primary debulking surgery (preferably triaged by "Fagotti" diagnostic laparoscopy)
- HIPEC is an option after IDS or DIDS
- Sufficiently good bone marrow, liver, and renal function to receive chemotherapy and subsequently undergo surgery
Who cannot join
- Pregnancy
- Synchronous malignancies at the time of diagnosis or in the 3 years prior to starting the study treatment
- Comorbidities that may contraindicate surgery or chemotherapy as planned per protocol
- Mucinous, clear-cell, carcinosarcoma or low-grade serous adenocarcinoma histological subtypes
- Stable disease or progression of disease (preferably triaged by "Fagotti" diagnostic laparoscopy) after 6 cycles of NACT, before DIDS.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, International, Multi-center, Interventional Trial of Advanced Epithelial Ovarian Cancer Patients Offered Three Cycles of Neoadjuvant Chemotherapy (NACT) and Triaged With KELIM Score. Patients With Favorable Score Will Undergo Interval Debulking Surgery (IDS) Followed by Another 3 Cycles of NACT, While Those With Unfavorable Will Undergo Another 3 Cycles of NACT Followed by Delayed Interval Debulking Surgery (DIDS).
A prospective, international, multi-center, interventional trial of advanced epithelial ovarian cancer patients offered three cycles of neoadjuvant chemotherapy (NACT) and triaged with KELIM score. Patients with favorable score will undergo interval debulking surgery (IDS) followed by another 3 cycles, while those with unfavorable score will undergo another 3 cycles of NACT followed by delayed interval debulking surgery (DIDS).
Read the detailed description
Primary debulking surgery (PDS) followed by adjuvant chemotherapy is the cornerstone of advanced ovarian cancer treatment. However, frail patients, patients with high tumor burden in the upper abdomen or extra-abdominal metastases may benefit from neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). In recent years, three randomized non-inferiority trials have demonstrated that NACT is a valid alternative to PDS. Similarly, the preliminary results from the TRUST trial showed that the primary endpoint of overall survival (OS) was not met, with numerical longer OS in PDS group compared to NACT in non-frail ovarian cancer patients. The optimal number of NACT cycles has not yet been established. Most studies in the literature recommend 3-4 cycles. However, in real-world clinical practice some patients receive more than 5 cycles before surgery, so delayed interval debulking surgery (DIDS) is proposed as an alternative. The rationale is to allow for maximal tumor shrinkage and improved likelihood of complete gross resection, while reducing perioperative morbidity. Retrospective data show that DIDS may be considered as an alternative for advanced ovarian cancer patients with a high tumor burden, when complete gross resection cannot be achieved during IDS.
Furthermore, the success of the above-mentioned treatment plans depends on tumor chemosensitivity and the ability to achieve complete gross resection, because residual disease after cytoreduction remains the most important prognostic factor. On the other hand, 15-20% of patients with advanced ovarian cancer will be poor responders to chemotherapy, so there is the need for accurate non-invasive chemo-sensitivity predictors to guide treatment decisions in the first-line setting, which is acknowledged by ESGO and ESMO. Monitoring of CA-125 decline during chemotherapy for the prediction of treatment response (13) and as a way to overcome imaging limitations, has been one of the main points of research in ovarian cancer patients. The ELIMination rate constant K (KELIM), a modeled kinetic parameter based on CA-125 measurements during the first 100 days of systemic therapy (adjuvant of neoadjuvant chemotherapy), has emerged as a valuable predictor. It is a mathematical modeling method based not on absolute values of the biomarker, but on the longitudinal kinetics (CA-125 elimination) during treatment, completely independent of renal function. Retrospective data show that KELIM score is an independent prognostic biomarker for survival outcomes, that can predict chemosensitivity, and that can safely triage patients undergoing NACT and guide who will benefit from IDS and DIDS, respectively.
- Conditions
- Ovarian Cancer
- Being tested
- 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS, 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDSProcedure or surgery
3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS
3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACTProcedure or surgery
3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
| Study group | Role | What they receive |
|---|---|---|
| ARM A: IDS | Active comparator | 3 cycles of NACT with a favorable KELIM score underwent IDS followed by 3 cycles of NACT Receives: Procedure: 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT |
| ARM B: DIDS | Experimental | 3 cycles of NACT with an unfavorable KELIM score will undergo 3 cycles of NACT followed by DIDS Receives: Procedure: 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: After 5 years from last patient enrollment
Secondary outcomes (4)
Progression free survival (PFS)
Measured: After 2 years from last patient enrollment.
Complete gross resection rate (residual disease: 0 cm)
Measured: After a month from cytoreduction
Postoperative complications (Clavien-Dindo classification)
Postoperative complications will be graded using the Clavien-Dindo classification of surgical complications, which ranges from Grade I to Grade V, with higher grades indicating more severe complications and Grade V representing death
Measured: After a month after cytoreduction
Quality of life (QoL) (EORTC QLQ-C30 questionnaire)
Health-related quality of life will be assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), scored from 0 to 100. For the global health and functional scales, higher scores indicate better functioning/quality of life, whereas for symptom scales higher scores indicate greater symptom burden (worse outcome)
Measured: After a month from cytoreduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * ARM A: 3 cycles of NACT with a favorable KELIM score will undergo IDS followed by 3 cycles of NACT * ARM B: 3 cycles of NACT with an unfavorable KELIM score will undergo 3 more cycles of NACT followed by DIDS
- Masking
- None (open label)
- Enrolment
- 485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Zouzoulas, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios Tsolakidis, Dr.Prof., Principal investigator, Artistotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382479
- Sponsor's protocol ID
- 2022-Β2015-230
- Acronym
- NACT-KELIM ID
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.
Publications
Zouzoulas D, Tsolakidis D, Tzitzis P, Sofianou I, Chatzistamatiou K, Theodoulidis V, Topalidou M, Timotheadou E, Grimbizis G. The Use of CA-125 KELIM to Identify Which Patients Can Achieve Complete Cytoreduction after Neoadjuvant Chemotherapy in High-Grade Serous Advanced Ovarian Cancer. Cancers (Basel). 2024 Mar 24;16(7):1266. doi: 10.3390/cancers16071266.
PubMed 38610943Zouzoulas D, Sofianou I, Tzitzis P, Theodoulidis V, Chatzistamatiou K, Timotheadou E, Grimbizis G, Tsolakidis D. The Role of Delayed Interval Debulking Surgery (DIDS) in the Surgical Treatment of Advanced Epithelial Ovarian Cancer: A Retrospective Cohort from an ESGO-Certified Center. Med Sci (Basel). 2025 Oct 2;13(4):217. doi: 10.3390/medsci13040217.
PubMed 41133497
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, International, Multi-center, Interventional Trial of Advanced Epithelial Ovarian Cancer Patients Offered Three Cycles of Neoadjuvant Chemotherapy (NACT) and Triaged With KELIM Score. Patients With Favorable Score Will Undergo Interval Debulking Surgery (IDS) Followed by Another 3 Cycles of NACT, While Those With Unfavorable Will Undergo Another 3 Cycles of NACT Followed by Delayed Interval Debulking Surgery (DIDS).
- ClinicalTrials.gov ID
- NCT07382479
- Acronym / sponsor ID
- NACT-KELIM ID / 2022-Β2015-230
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 2 Feb 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.
A prospective, international, multi-center, interventional trial of advanced epithelial ovarian cancer patients offered three cycles of neoadjuvant chemotherapy (NACT) and triaged with KELIM score. Patients with favorable score will undergo interval debulking surgery (IDS) followed by another 3 cycles, while those with unfavorable score will undergo another 3 cycles of NACT followed by delayed interval debulking surgery (DIDS).
Detailed description
Primary debulking surgery (PDS) followed by adjuvant chemotherapy is the cornerstone of advanced ovarian cancer treatment. However, frail patients, patients with high tumor burden in the upper abdomen or extra-abdominal metastases may benefit from neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). In recent years, three randomized non-inferiority trials have demonstrated that NACT is a valid alternative to PDS. Similarly, the preliminary results from the TRUST trial showed that the primary endpoint of overall survival (OS) was not met, with numerical longer OS in PDS group compared to NACT in non-frail ovarian cancer patients. The optimal number of NACT cycles has not yet been established. Most studies in the literature recommend 3-4 cycles. However, in real-world clinical practice some patients receive more than 5 cycles before surgery, so delayed interval debulking surgery (DIDS) is proposed as an alternative. The rationale is to allow for maximal tumor shrinkage and improved likelihood of complete gross resection, while reducing perioperative morbidity. Retrospective data show that DIDS may be considered as an alternative for advanced ovarian cancer patients with a high tumor burden, when complete gross resection cannot be achieved during IDS.
Furthermore, the success of the above-mentioned treatment plans depends on tumor chemosensitivity and the ability to achieve complete gross resection, because residual disease after cytoreduction remains the most important prognostic factor. On the other hand, 15-20% of patients with advanced ovarian cancer will be poor responders to chemotherapy, so there is the need for accurate non-invasive chemo-sensitivity predictors to guide treatment decisions in the first-line setting, which is acknowledged by ESGO and ESMO. Monitoring of CA-125 decline during chemotherapy for the prediction of treatment response (13) and as a way to overcome imaging limitations, has been one of the main points of research in ovarian cancer patients. The ELIMination rate constant K (KELIM), a modeled kinetic parameter based on CA-125 measurements during the first 100 days of systemic therapy (adjuvant of neoadjuvant chemotherapy), has emerged as a valuable predictor. It is a mathematical modeling method based not on absolute values of the biomarker, but on the longitudinal kinetics (CA-125 elimination) during treatment, completely independent of renal function. Retrospective data show that KELIM score is an independent prognostic biomarker for survival outcomes, that can predict chemosensitivity, and that can safely triage patients undergoing NACT and guide who will benefit from IDS and DIDS, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * ARM A: 3 cycles of NACT with a favorable KELIM score will undergo IDS followed by 3 cycles of NACT * ARM B: 3 cycles of NACT with an unfavorable KELIM score will undergo 3 more cycles of NACT followed by DIDS
| Arm | Type | Receives |
|---|---|---|
| ARM A: IDS | Active comparator | Procedure: 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT3 cycles of NACT with a favorable KELIM score underwent IDS followed by 3 cycles of NACT |
| ARM B: DIDS | Experimental | Procedure: 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS3 cycles of NACT with an unfavorable KELIM score will undergo 3 cycles of NACT followed by DIDS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 - 85 years old
- Histologically proven epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, high grade serous or endometrioid
- ECOG Performance status 0 - 1
- Documented International Federation of Gynecologic Oncology (FIGO) 2014 stage IIIB, IIIC or IVA unfit and/or with unresectable disease for complete primary debulking surgery (preferably triaged by "Fagotti" diagnostic laparoscopy)
- HIPEC is an option after IDS or DIDS
Key exclusion criteria (5 listed)
- Pregnancy
- Synchronous malignancies at the time of diagnosis or in the 3 years prior to starting the study treatment
- Comorbidities that may contraindicate surgery or chemotherapy as planned per protocol
- Mucinous, clear-cell, carcinosarcoma or low-grade serous adenocarcinoma histological subtypes
- Stable disease or progression of disease (preferably triaged by "Fagotti" diagnostic laparoscopy) after 6 cycles of NACT, before DIDS.
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 |
|---|---|---|
| 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS | Procedure or surgery | ARM B: DIDS |
| 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT | Procedure or surgery | ARM A: IDS |
Primary outcome
Overall survival (OS)
Time frame: After 5 years from last patient enrollment
4 secondary outcomes
Progression free survival (PFS)
Time frame: After 2 years from last patient enrollment.
Complete gross resection rate (residual disease: 0 cm)
Time frame: After a month from cytoreduction
Postoperative complications (Clavien-Dindo classification)
Time frame: After a month after cytoreduction
Quality of life (QoL) (EORTC QLQ-C30 questionnaire)
Time frame: After a month from cytoreduction
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 5 Feb 2026.
- Background: PubMed 38610943Zouzoulas D, Tsolakidis D, Tzitzis P, Sofianou I, Chatzistamatiou K, Theodoulidis V, Topalidou M, Timotheadou E, Grimbizis G. The Use of CA-125 KELIM to Identify Which Patients Can Achieve Complete Cytoreduction after Neoadjuvant Chemotherapy in High-Grade Serous Advanced Ovarian Cancer. Cancers (Basel). 2024 Mar 24;16(7):1266. doi: 10.3390/cancers16071266.
- Background: PubMed 41133497Zouzoulas D, Sofianou I, Tzitzis P, Theodoulidis V, Chatzistamatiou K, Timotheadou E, Grimbizis G, Tsolakidis D. The Role of Delayed Interval Debulking Surgery (DIDS) in the Surgical Treatment of Advanced Epithelial Ovarian Cancer: A Retrospective Cohort from an ESGO-Certified Center. Med Sci (Basel). 2025 Oct 2;13(4):217. doi: 10.3390/medsci13040217.
- Individual participant dataSharing planned: No. Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.
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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.
Dimitrios Tsolakidis, Dr.Prof. principal investigator
Artistotle University of Thessaloniki
Questions about this trial
What is this clinical trial studying?
A study testing 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS and 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT in people with Ovarian Cancer, run by Aristotle University Of Thessaloniki.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Dimitrios Zouzoulas, MD, MSc, PhD (+306946536065, dzouzoulas@hotmail.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: After 5 years from last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07382479, which also lists 2 linked publications.
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 5 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.