Timing of surgery after chemotherapy for advanced ovarian cancer

Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery

This study is testing whether having surgery sooner or later after chemotherapy helps women with advanced ovarian cancer live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Alexandria University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Alexandria)
• Trial ID: NCT06404671 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the optimal timing for interval cytoreductive surgery (ICS) following neoadjuvant chemotherapy (NACT) in women with advanced high-grade serous ovarian cancer who are not candidates for upfront surgery. Participants will be randomized to receive either early or delayed ICS after completing 3 or 6 cycles of NACT. The study aims to evaluate the survival benefits associated with different surgical timings, addressing the logistical and patient-specific factors that may affect treatment outcomes. By comparing these approaches, the trial seeks to provide insights into improving survival rates for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are female patients aged 18 to 75 with high-grade serous ovarian cancer at FIGO stage IIIB-IV who are unsuitable for upfront cytoreductive surgery.

Not a fit: Patients with metastatic ovarian carcinoma or those with other types of ovarian cancer, such as low-grade serous or clear cell carcinoma, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival outcomes for women with advanced ovarian cancer by identifying the most effective timing for surgery after chemotherapy.

How similar studies have performed: While there have been studies on neoadjuvant chemotherapy and interval surgery, this specific approach to timing has not been extensively tested, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Female Patients aged 18 to 75 years.
2. International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
3. Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
4. ECOG performance status: 0 or 1.
5. Resectable disease by laparoscopic assessment after 3 cycles of NACT.
6. Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
7. 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.

Exclusion Criteria:

1. Metastatic ovarian carcinoma.
2. Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
3. Presence of pregnancy or breast-feeding.
4. History of other invasive malignancies in the previous 5 years.
5. History of a recent \< 6 month cerebrovascular accident.
6. Uncontrolled systemic disease or contraindication to chemotherapy.
7. Progressive disease on NACT.
8. Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
9. Severe comorbidities (ACCI \>= 4)

Where this trial is running

Alexandria

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

Study contacts

• Study coordinator: Hayat Sharaf, MsC

Conditions Ovarian Epithelial Cancer; high grade serous; advanced primary ovarian cancer; interval cytoreduction