Timing of surgery after chemotherapy for advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Elshatby Maternity University Hospital
  Alexandria, Egypt Recruiting

Study contacts

• Study coordinator: Hayat Sharaf, MsC
• Email: h_mohammed14@alexmed.edu.eg
• Phone: 00201025774942

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.