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