NeoAdjuvant ChemoTherapy With KELIM Guided Interval vs. Delayed Interval Debulking Surgery
Starting soon · Not applicable
Conditions studied: Ovarian Cancer
In brief
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).
Key facts
- Study ID
- NCT07382479
- Run by
- Aristotle University Of Thessaloniki
- People needed
- 485
- Starts
- 2026-04-01
- Expected to finish
- 2034-04-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
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.
Full record on ClinicalTrials.gov
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