Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Recruiting now · Not applicable

Conditions studied: Ovarian Epithelial Cancer

In brief

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).

Key facts

Study ID

NCT06404671

Run by

Alexandria University

People needed

250

Starts

2023-09-15

Expected to finish

2029-03-20

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Resectable disease by laparoscopic assessment after 3 cycles of NACT.
• Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
• Estimated life expectancy of > 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.

You may not qualify if…

• 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.
• History of a recent < 6 month cerebrovascular accident.
• Uncontrolled systemic disease or contraindication to chemotherapy.
• Progressive disease on NACT.
• Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
• Severe comorbidities (ACCI >= 4)

Where it is running

• Elshatby Maternity University Hospital — Alexandria, Egypt (enrolling)

Full record on ClinicalTrials.gov

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