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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorAristotle University Of Thessaloniki

About this trial

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).

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS
  • 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT

Treatment groups

485 Participants
are divided into 2 treatment groups

Locations

This trial has no locations