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Observing women with endometrial cancer after standard treatment

SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)

Observational Memorial Sloan Kettering Cancer Center · NCT04291612

This study looks at how often endometrial cancer comes back and if women develop swelling after standard treatment, focusing on those who have had surgery for their cancer.

Quick facts

Study typeObservational
Enrollment1715 (estimated)
Ages18 Years and up
SexFemale
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy, radiation
Locations19 sites (Hartford, Connecticut and 18 other locations)
Trial IDNCT04291612 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the recurrence rates of endometrial cancer and the incidence of lymphedema following standard treatment in women diagnosed with endometrioid adenocarcinoma. Participants will undergo physical examinations and be monitored for outcomes related to their treatment. The study focuses on women who are suitable candidates for surgery and have specific eligibility criteria regarding their cancer stage and treatment history.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with a confirmed diagnosis of endometrioid adenocarcinoma who are eligible for surgical treatment.

Not a fit: Patients with extrauterine disease or those who have received prior treatments such as neoadjuvant chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effects of standard treatment for endometrial cancer, potentially improving patient management and outcomes.

How similar studies have performed: Other studies have explored similar observational approaches in cancer treatment outcomes, indicating a potential for valuable findings, although this specific focus may be novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Screening Inclusion Criteria:

* ECOG performance status 0-1 or KPS ≥ 70%
* Age ≥ 18 years
* Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage
* No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )
* Suitable candidate for surgery
* Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
* No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
* Approved and signed informed consent
* No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
* No history of prior pelvic or abdominal radiotherapy

Screening Exclusion Criteria:

* Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage \> I)
* Contraindication for SLN mapping
* The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy

Eligibility Inclusion Criteria

Patients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below.

Study Cohort (n=182)

A patient will be enrolled in the study cohort if all the following criteria are met:

* At surgery, the patient must undergo:

  * Hysterectomy
  * Bilateral salpingo-oophorectomy, unless already performed (including allowing unilateral salpingo-oophorectomy if unilateral salpingo-oophorectomy already performed)
  * Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)
* On the final pathologic report, the patient must have a diagnosis of:

  * Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with \<50% myometrial invasion, including non-invasive disease)
  * Negative pelvic peritoneal cytology
* Adjuvant treatment as recommended by the multidisciplinary team must be as follows:

  * No adjuvant treatment, or
  * Intravaginal radiation only

Eligibility Exclusion Criteria

* There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes
* Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)
* Hysterectomy is not performed
* Bilateral salpingo-oophorectomy is not performed, unless already performed (unilateral salpingo-oophorectomy is allowed if unilateral salpingo-oophorectomy already performed)
* Failed unilateral or bilateral SLN mapping
* Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
* Patient undergoes a radical type C hysterectomy
* Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion \<50%
* Stage IB Grade 3 endometrioid cancer
* Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology
* Empty unilateral or bilateral sentinel lymph nodal packet(s)
* Positive peritoneal cytology

Where this trial is running

Hartford, Connecticut and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial CancerEndometrioid AdenocarcinomaEndometrial Cancer Stage I20-067Memorial Sloan Kettering Cancer Center
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.