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).
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)
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
Parallel
3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS
Procedure/Surgery3 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
Procedure/Surgery3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT
Overall survival (OS)
Progression free survival (PFS)
Complete gross resection rate (residual disease: 0 cm)
Postoperative complications (Clavien-Dindo classification)
Postoperative complications will be graded using the Clavien-Dindo classification of surgical complications, which ranges from Grade I to Grade V, with higher grades indicating more severe complications and Grade V representing death
Quality of life (QoL) (EORTC QLQ-C30 questionnaire)
Health-related quality of life will be assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), scored from 0 to 100. For the global health and functional scales, higher scores indicate better functioning/quality of life, whereas for symptom scales higher scores indicate greater symptom burden (worse outcome)
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