NeoAdjuvant ChemoTherapy With KELIM Guided Interval vs. Delayed Interval Debulking Surgery (NACT-KELIM ID)

February 3, 2026 updated by: Dimitrios Zouzoulas, Aristotle University Of Thessaloniki

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

485

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ARM A: IDS
3 cycles of NACT with a favorable KELIM score underwent IDS followed by 3 cycles of NACT
Procedure: 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
Experimental: ARM B: DIDS
3 cycles of NACT with an unfavorable KELIM score will undergo 3 cycles of NACT followed by DIDS
Procedure: 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS
3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: After 5 years from last patient enrollment
After 5 years from last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: After 2 years from last patient enrollment.
After 2 years from last patient enrollment.
Complete gross resection rate (residual disease: 0 cm)
Time Frame: After a month from cytoreduction
After a month from cytoreduction
Postoperative complications (Clavien-Dindo classification)
Time Frame: After a month after cytoreduction
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
After a month after cytoreduction
Quality of life (QoL) (EORTC QLQ-C30 questionnaire)
Time Frame: After a month from cytoreduction
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)
After a month from cytoreduction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Dimitrios Tsolakidis, Dr.Prof., Artistotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-Β2015-230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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