Clinical trial · Interventional
Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer
Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients With Stage III and IV Epithelial Ovarian Cancer
NCT06883409CI-TRIAL-00087729recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a study that aims to demonstrate the non-inferiority of minimally invasive surgery versus open surgery, as an approach for patients with advanced ovarian cancer who received neoadjuvant chemotherapy, giving them the benefits of laparoscopic surgery. This way they can continue with their complementary treatment.
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 Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interval Cytoreduction Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with advance ovarian cancer already treated with NACT and eligible for MIS
- description
- Were enrolled patients who met the inclusion criteria by receiving 3 to 4 cycles of NACT, with ca 125 up to 200 U/ml, and partial or complete response by image (PET-CT), and subsequently underwent laparoscopic approach.
- interventionNames
- Procedure: Interval Cytoreduction Surgery
Primary outcomes (1)
- measure
- Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients with Stage III and IV Epithelial Ovarian Cancer
- timeFrame
- 1 year
- description
- Efficiency of laparoscopic interval surgery will be evaluated according to percentage of patients who achieved optimal cytoreduction compared to the reported rates in the literature (70 -80%) and the measured frequency of complications during the 30 day postoperative period. Severity of complications will be measured using the Clavien Dindo scale (Grade I: any deviation from the normal post operative course without need for pharmacological treatment - Grade V: death)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of epithelial ovarian cancer (all subtypes of epithelial ovarian cancer) in stage III-IV * Partial and complete response to treatment with QTNA after 3-4 cycles, evaluated by PET-CT imaging study, patients that the functional unit decides to incorporate into the project. * Ca 125 which will have to be less than 200 * ECOG 0 to 2 without medical contraindication to perform surgery (≤ ASA 2 or ≤ Goldman 2). Exclusion Criteria: * Partial response with persistence of ascites or pleural effusion. * With unresectability criteria (multiple intrahepatic liver metastases, retroperitoneal lymph node conglomerates \>2cm above the renal lymph nodes, metastatic disease above the diaphragm, multiple intestinal involvement and mesentery retraction).
References
Publications (0)
Data not yet available
No reference posted for this study.