Clinical trial · Interventional
Timing of Surgery After Neoadjuvant 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Epithelial Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delayed interval cytoreductive surgery (DICS) | Procedure | — | UNRESOLVED |
| Early interval cytoreductive surgery (EICS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- delayed interval cytoreduction surgery (DICS)
- description
- delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks
- interventionNames
- Procedure: Delayed interval cytoreductive surgery (DICS)
- type
- ACTIVE_COMPARATOR
- label
- Early interval cytoreduction surgery (EICS)
- description
- Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks
- interventionNames
- Procedure: Early interval cytoreductive surgery (EICS)
Primary outcomes (2)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
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