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Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

RecruitingNAAges 18 Years - 75 YearsFemaleAlexandria University
NCT06404671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

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

1 site
Elshatby Maternity University Hospital
Alexandria, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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