NCT06404671 Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer
| NCT ID | NCT06404671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexandria University |
| Condition | Ovarian Epithelial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2023-09-15 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06404671 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Ovarian Epithelial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06404671 currently recruiting?
Yes, NCT06404671 is actively recruiting participants. Contact the research team at h_mohammed14@alexmed.edu.eg for enrollment information.
Where is the NCT06404671 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT06404671 clinical trial?
NCT06404671 is sponsored by Alexandria University. The trial plans to enroll 250 participants.
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