Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective, Multicenter, Cohort Study

Recruiting

• 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

• Registration Number: NCT06689956
• Lead Sponsor: Mayo Clinic

Brief Summary

This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate whether patients with low-risk endometrial cancer and isolated tumor cells (ITC) will have worse recurrence-free survival (RFS) than a historical cohort of similar patients with negative nodes.

OUTLINE: This is an observational study.

Patients undergo tissue sample collection and have their medical records reviewed on study.

Study Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Study Start: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2029-10-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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) identified in SLN.
  • Willingness to forego adjuvant treatment.
  • Research consent provided.

Exclusion Criteria

• Prior neoadjuvant chemotherapy.

  • Planning to receiving adjuvant treatment.
  • Presence of synchronous 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.
  • No prior invasive cancer diagnosis within 5 years of study entry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival (RFS)	Up to 5 years	RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation.

Secondary Outcome Measures

Name	Time	Method
Non-vaginal RFS	Up to 5 years	Non-vaginal RFS is defined as the interval from the date of surgery to the date of the first of the following events: non-vaginal recurrence or death due to any cause.
Overall Survival (OS)	Up to 5 years	Overall survival is defined as the time from surgery to death due to any cause.

Trial Locations

Locations (20)

University of Udine; 🇮🇹 Udine, UD, Italy

Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale; 🇮🇹 Naples, Italy

Hospital Materno of Las Palmas; 🇪🇸 Las Palmas, Spain

Ospedale Regionale di Lugano, Civico; 🇨🇭 Lugano, Switzerland

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Medical University of Vienna; 🇦🇹 Vienna, Austria

AC Camargo Cancer Center; 🇧🇷 São Paulo, Brazil

Sunnybrook Health Sciences, University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Hopital Maisonneuve Rosemont; 🇨🇦 Montréal, Quebec, Canada

Institut Universitaire du Cancer Toulouse Oncopole; 🇫🇷 Toulouse, France

University Hospital Essen; 🇩🇪 Essen, Germany

Meir Medical Center, Faculty of Medicine - Tel-Aviv University; 🇮🇱 Kefar Sava, Israel

Ospedale Michele e Pietro Ferrero; 🇮🇹 Verduno, CN, Italy

IRCCS Fondazione San Gerardo dei Tintori; 🇮🇹 Monza, MB, Italy

Fondazione IRCCS Istituto Nazionale Tumori; 🇮🇹 Milano, MI, Italy

European Institute of Oncology; 🇮🇹 Milano, MI, Italy

Policlinico Universitario Fondazione Agostino Gemelli; 🇮🇹 Roma, RM, Italy