Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorAlexandria University

About this trial

Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).

Eligibility criteria

Qualifiers

Female Patients aged 18 to 75 years.

International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.

Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.

ECOG performance status: 0 or 1.

Disqualifiers

Metastatic ovarian carcinoma.

Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).

Presence of pregnancy or breast-feeding.

History of other invasive malignancies in the previous 5 years.

Trial design

Treatments tested in this trial

  • Delayed interval cytoreductive surgery (DICS)
  • Early interval cytoreductive surgery (EICS)

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators