Clinical trial · Interventional
LYmphadenectomy After NeoAdjuvant Chemotherapy
Lymphadenectomy After Neo-Adjuvant Chemotherapy in Ovarian Neoplasm
NCT01724944CI-TRIAL-00008476LYANAunknownPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy. Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.
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 |
|---|---|---|---|
| Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systematic pelvic and aortic lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Systematic Lymphadenectomy
- interventionNames
- Procedure: Systematic pelvic and aortic lymphadenectomy
Primary outcomes (2)
- measure
- Percentage of positive lymph nodes after neoadjuvant chemotherapy
- timeFrame
- 6 months
- measure
- Evaluation of complications related to the surgical procedure
- timeFrame
- 6 months
Secondary outcomes (2)
- measure
- Evaluation of disease-free interval (DFS)
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75 years * Patients affected by advanced ovarian cancer (FIGO stage III-IV) who underwent \> 2 to \<7 cycles of neoadjuvant chemotherapy based on platinum and taxanes. * Clinical response (instrumental and serological) complete or partial. * Residual intra-abdominal tumor \<1 cm. * Absence of disease macroscopically evident in lymph nodes (\> 1 cm) * Life expectancy of at least 4 weeks * ECOG PS ≤ 2 * Adequate respiratory function, hepatic, cardiac, bone marrow and renal function (creatinine clearance\> 60 mL / min according to the Cockroft formula) * Patient psychologically able to follow the study procedures Exclusion Criteria: * Patients with severe impairment of lung function, or liver failure, such as not to allow access in safety in the operating room. * Not epithelial ovarian neoplasms or borderline tumors * Other invasive cancer in the last 5 years or signs of recurrence or activity * Patients with intra-abdominal residual tumor\> 1 cm * Patients with the presence of bulky nodes (\> 1 cm) in the intra-operative evaluation * Diseases of the lymphatic system (including lymphatic edema of unknown origin)
References
Publications (0)
Data not yet available
No reference posted for this study.