Clinical trial · Interventional
NeoAdjuvant ChemoTherapy With KELIM Guided Interval vs. Delayed Interval Debulking Surgery
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT | Procedure | — | UNRESOLVED |
| 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM A: IDS
- description
- 3 cycles of NACT with a favorable KELIM score underwent IDS followed by 3 cycles of NACT
- interventionNames
- Procedure: 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
- type
- EXPERIMENTAL
- label
- ARM B: DIDS
- description
- 3 cycles of NACT with an unfavorable KELIM score will undergo 3 cycles of NACT followed by DIDS
- interventionNames
- Procedure: 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS
Primary outcomes (1)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDZouzoulas 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. PMID 38610943
- BACKGROUNDZouzoulas 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. PMID 41133497