NeoAdjuvant ChemoTherapy With KELIM Guided Interval vs. Delayed Interval Debulking Surgery

NCT07382479 | Not Yet Recruiting

• 1 other identifier: 2022-Β2015-230
• Study Type: interventional
• Target: 485
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  After 5 years from last patient enrollment

Secondary Outcomes (4)

• Progression free survival (PFS)

  After 2 years from last patient enrollment.

• Complete gross resection rate (residual disease: 0 cm)

  After a month from cytoreduction

• Postoperative complications (Clavien-Dindo classification)

  After a month after cytoreduction

• Quality of life (QoL) (EORTC QLQ-C30 questionnaire)

  After a month from cytoreduction

Study Arms (2)

ARM A: IDS

ACTIVE COMPARATOR

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

ARM B: DIDS

EXPERIMENTAL

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

Interventions

3 cycles of NACT with favorable KELIM score will undergo 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

ARM A: IDS

3 cycles of NACT with unfavorable KELIM score will receive 3 more 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

ARM B: DIDS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Related Publications (2)

• 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.

  PMID: 38610943 BACKGROUND

• Zouzoulas 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 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Dimitrios Tsolakidis, Dr.Prof.

  Artistotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Zouzoulas, MD, MSc, PhD

CONTACT

+306946536065; dzouzoulas@hotmail.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecological Oncologist, MSc, PhD, FEBS-BS

Model Details: * 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

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2034
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share