Clinical trial · Interventional
Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus
Sentinel Lymph Node Sampling Versus Systematic Pelvic Lymphadenectomy on the Prognosis for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus Before Surgery: a Non-inferiority Randomized Controlled Trial
NCT04276532CI-TRIAL-00111241active not recruitingN/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)
Aim To investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Middle-high Risk Endometrial Cancer | — | UNRESOLVED | — |
| Prognosis | — | UNRESOLVED | — |
| Sentinel Lymph Node Sampling | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pelvic lymphonodectomy (PLN) | Procedure | — | UNRESOLVED |
| sentinel lymph node sampling (SLN) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sentinel lymph node sampling
- description
- Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN)
- interventionNames
- Procedure: sentinel lymph node sampling (SLN)
- type
- ACTIVE_COMPARATOR
- label
- Pelvic lymphadenectomy
- description
- Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling
- interventionNames
- Procedure: pelvic lymphonodectomy (PLN)
Primary outcomes (1)
- measure
- The 2-year progression-free survival (2-year PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Older than 18 years old; 2. Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors: 1. disease limited to the uterus on image study (MRI, CT or ultrasound); 2. including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma 3. excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion \<50%); 4. with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer, molecular classification of p53abn, LVSI; 5. diagnosis should be confirmed by at least two senior clinicians; 3. Be able to undergo staging surgery. Exclusion Criteria: 1. During pregnancy or perinatal period; 2. With synchronous malignancies or other malignancies than endometrial cancer in 3 years, except for non-melanoma skin cancer; 3. With history of important organs transplantation; 4. With immune diseases requiring taking immunosuppressants 5. With severe mental illness or brain function disorders 6. With history of drug abuse; 7. Allergic to contrast agent; 8. Still participating in other clinical trials; 9. Not willing to accept surgery or trial protocol; 10. Not eligible for surgery; 11. Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail; 12. Had retroperitoneum lymph node dissection for other reasons.
References
Publications (1)
- DERIVEDGuan J, Xue Y, Zang RY, Liu JH, Zhu JQ, Zheng Y, Wang B, Wang HY, Chen XJ. Sentinel lymph Node mapping versus systematic pelvic lymphadenectomy on the prognosis for patients with intermediate-high-risk Endometrial Cancer confined to the uterus before surgery: trial protocol for a non-inferiority randomized controlled trial (SNEC trial). J Gynecol Oncol. 2021 Jul;32(4):e60. doi: 10.3802/jgo.2021.32.e60. PMID 34085796