Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Korábbi kezelés

• Patients who are eligible for primary debulking surgery (PDS)
• Patients who have already started NACT outside the study centers, except those who have received only one cycle within 7 days and the baseline CA125 value within 3 days of NACT (normal cut-off 35 U/ml) is available
• Patients who have contraindications to platinum-based chemotherapy

Más betegség

• Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
• Patients with history of other malignancies within five years
• Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.

Egyéb

• Patients with mucinous and neuroendocrine histology
• Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone
• Patients who are not fit for PDS because of medical morbidities or refusal of operation
• Patients who participate in other interventional studies
• Patients who are pregnant or breastfeeding

• Patients aged 18 years old or older
• Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment
• Patients who can sign the informed consent
• Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS
• Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis.
• Patients who are planned for neoadjuvant chemotherapy (NACT) using 3-weekly carboplatin and paclitaxel. Those who have received one cycle of NACT may be eligible if the CA125 schedule of the study group can be matched.
• Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal)
• Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT
• Patients with adequate hematologic, liver and renal functions for chemotherapy
• Patients who agree to receive adjuvant chemotherapy after IDS. The total number of NACT and adjuvant chemotherapy should be four or above, up to maximum of 9 cycles.
• Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.
• Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.