Clinical trial · Interventional
Comparison of Nodal Staging in Endometrial Cancer
Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer
NCT04970368CI-TRIAL-00072759terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective staging | Procedure | — | UNRESOLVED |
| Sentinel node procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sentinel Node Surgical Staging
- interventionNames
- Procedure: Sentinel node procedure
- type
- EXPERIMENTAL
- label
- Selective Surgical Staging
- interventionNames
- Procedure: Selective staging
Primary outcomes (1)
- measure
- Recurrence-free survival rate
- timeFrame
- 5 years
- description
- Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy * Histologically or cytologically confirmed endometrioid-type endometrial cancer confined to the uterine corpus * No clinical evidence of extra-uterine disease on pre-operative evaluation. * Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy. * Age ≥18 years. * Life expectancy (estimated survival) of at least 6 months. * AST(SGOT)/ALT(SGPT) \< 3.0X upper limit of normal * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * GOG/ECOG Performance Status greater than 2 * Non-endometrioid cell type * Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam * Previous vaginal, pelvic or abdominal irradiation * Chemotherapy, hormone therapy or immunotherapy directed at the present disease * Previous pelvic lymphadenectomy or retroperitoneal surgery * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.