Sign in

NCT07382479Not yet recruiting

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 · Last updated 5 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
485 (estimated)
First submitted
27 Jan 2026
Start date
1 Apr 2026
Primary completion date
1 Apr 2031
Lead sponsor
Aristotle University Of Thessaloniki
NCT number
NCT07382479

What you commit to

  • Study type: Interventional
  • Planned participants: 485
  • From 1 Apr 2026 to the primary completion date, 1 Apr 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Stable disease or progression of disease (preferably triaged by "Fagotti" diagnostic laparoscopy) after 6 cycles of NACT, before DIDS.

Other

  • Pregnancy
  • Mucinous, clear-cell, carcinosarcoma or low-grade serous adenocarcinoma histological subtypes

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.