Evaluating outcomes in low-risk endometrial cancer with isolated tumor cells in lymph nodes
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
Mayo Clinic · NCT06689956
This study is trying to see if patients with low-risk endometrial cancer who have isolated tumor cells in their lymph nodes have a higher chance of cancer coming back compared to similar patients without those cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 212 (estimated) |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Rochester, Minnesota and 19 other locations) |
| Trial ID | NCT06689956 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether patients with low-risk endometrial cancer who have isolated tumor cells in their sentinel lymph nodes experience worse recurrence-free survival compared to a historical cohort of similar patients with negative lymph nodes. The study involves collecting tissue samples and reviewing medical records to gather data on patient outcomes. By focusing on specific criteria such as tumor grade and lymphovascular space invasion, the study seeks to provide insights into the prognostic significance of isolated tumor cells in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with low-risk endometrial cancer, specifically FIGO Grade 1 or 2, who have isolated tumor cells in their sentinel lymph nodes.
Not a fit: Patients with prior neoadjuvant chemotherapy, those planning to receive adjuvant treatment, or those with more extensive disease in their lymph nodes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help refine treatment strategies for patients with low-risk endometrial cancer, potentially leading to better management and outcomes.
How similar studies have performed: Other studies have explored the significance of isolated tumor cells in various cancers, suggesting that this approach may yield valuable insights, although this specific focus on low-risk endometrial cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (\< 5 vessels involved) will be included. * Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging. * Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or \< 200 cells) * No adjuvant treatment after surgery * Research consent provided. Exclusion Criteria: * Prior neoadjuvant chemotherapy. * Planning to receive adjuvant treatment. * Presence of synchronous cancer (excluding non-melanoma skin cancer). * Extent of disease in SLN: micrometastasis (\> 0.2 to ≤ 2.0 mm) or macrometastasis (\> 2.0 mm). * Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. * Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer).
Where this trial is running
Rochester, Minnesota and 19 other locations
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
- Medical University of Vienna — Vienna, Austria (RECRUITING)
- AC Camargo Cancer Center — São Paulo, Brazil (RECRUITING)
- Sunnybrook Health Sciences, University of Toronto — Toronto, Ontario, Canada (RECRUITING)
- Hopital Maisonneuve Rosemont — Montreal, Quebec, Canada (RECRUITING)
- Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France (NOT_YET_RECRUITING)
- University Hospital Essen — Essen, Germany (NOT_YET_RECRUITING)
- Meir Medical Center, Faculty of Medicine - Tel-Aviv University — Kefar Sava, Israel (NOT_YET_RECRUITING)
- Ospedale Michele e Pietro Ferrero — Verduno, CN, Italy (NOT_YET_RECRUITING)
- IRCCS Fondazione San Gerardo dei Tintori — Monza, MB, Italy (NOT_YET_RECRUITING)
- Fondazione IRCCS Istituto Nazionale Tumori — Milan, MI, Italy (RECRUITING)
- European Institute of Oncology — Milan, MI, Italy (RECRUITING)
- Policlinico Universitario Fondazione Agostino Gemelli — Roma, RM, Italy (RECRUITING)
- University of Udine — Udine, UD, Italy (NOT_YET_RECRUITING)
- Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale — Naples, Italy (NOT_YET_RECRUITING)
- Hospital Materno Infantil Las Palmas — Las Palmas, Spain (RECRUITING)
- Hospital Universitario La Paz — Madrid, Spain (RECRUITING)
- Ospedale Regionale di Lugano, Civico — Lugano, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Gretchen E. Glaser, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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.
Conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023, Stage IA2 Endometrial Cancer FIGO 2023