Mapping lymph nodes in high-risk endometrial cancer patients
Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.
This study is testing if a new way of checking lymph nodes can help people with high-risk endometrial cancer get better treatment while causing fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Curitiba, Paraná and 4 other locations) |
| Trial ID | NCT03366051 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of sentinel lymph node (SLN) mapping followed by systematic lymphadenectomy in patients with high-risk endometrial cancer. Participants will be randomized into two groups: one receiving only SLN mapping and the other receiving SLN mapping followed by lymphadenectomy. The goal is to determine if SLN mapping can accurately identify lymph node metastases while minimizing the complications associated with complete lymphadenectomy. The study aims to improve staging and treatment outcomes for patients with high-grade histologies or deep myometrial invasion.
Who should consider this trial
Good fit: Ideal candidates include patients with high-grade endometrial cancer or those with significant myometrial invasion.
Not a fit: Patients with previous pelvic node dissection or extra-uterine disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce surgical complications while maintaining accurate staging for high-risk endometrial cancer patients.
How similar studies have performed: Previous studies have shown promising results with SLN mapping in lower-risk populations, but this study focuses on a higher-risk group, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * High grade histologies (endometrioid grade 3, serous, clear cell and carcinosarcoma) * Endometrioid grades 1 or 2 with myometrial invasion of ≥50% * Endometrioid grades 1 or 2 with cervical invasion * Clinically suitable to receive systematic lymphadenectomy * Consent statement Exclusion Criteria: * Previous hysterectomy in other institution * Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis) * Previous pelvic node dissection
Where this trial is running
Curitiba, Paraná and 4 other locations
- Hospital Erasto Gaertner — Curitiba, Paraná, Brazil (Recruiting)
- Hospital do Cancer de Barretos — Barretos, São Paulo, Brazil (Recruiting)
- AC Camargo Cancer Center — São Paulo, São Paulo, Brazil (Recruiting)
- Albert Einstein Hospital — São Paulo, São Paulo, Brazil (Recruiting)
- Sao Camilo Oncologia — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Glauco Baiocchi, MD, PhD — Department of Gynecologic Oncology - AC Camargo Cancer Center
- Study coordinator: Bruna Goncalves, RN, MSc
- Email: bruna.goncalves@accamargo.org.br
- Phone: 551121895110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.