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RecruitingObservational

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

NCT ID: NCT04291612Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-01

Summary

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Arms & interventions

  • OtherPhysical exam

    Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.

Outcome measures

Primary

  • Incidence of pelvic/non-vaginal recurrence at 36 months

    Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination

    Time frame: 36 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (13)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102

Recruiting
Jonathan Cosin, MD · Contact

University of Miami (Data Collection Only)

Miami, Florida, 33136

Not Yet Recruiting
Brian Clomovitz, MD · Contact

Miami Cancer Institute Baptist Health South Florida

Miami, Florida, 33143

Recruiting
John Paul Diaz, MD · Contact

ADVENTHEALTH (Data collection only)

Orlando, Florida, 32804

Recruiting
Robert Holloway, MD · Contact

Mayo Clinic (Data Collection and Data Analysis)

Rochester, Minnesota, 55905

Active Not Recruiting

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920

Recruiting
Nadeem Abu-Rustum, MD · Contact

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

Recruiting
Nadeem Abu-Rustum, MD · Contact

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645

Recruiting
Nadeem Abu-Rustum, MD · Contact

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, 11725

Recruiting
Nadeem Abu-Rustum, MD · Contact

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604

Recruiting
Nadeem Abu-Rustum, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Nadeem Abu-Rustum, MD · Contact

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553

Recruiting
Nadeem Abu-Rustum, MD · Contact

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

Recruiting
Martin Martino, MD · Contact

References

  • Grassi T, Mariani A, Cibula D, Soliman PT, Suman VJ, Weaver AL, Pedra Nobre S, Weigelt B, Glaser GE, Cappuccio S, Abu-Rustum NR. A prospective multicenter international single-arm observational study on the oncological safety of the sentinel lymph node algorithm in stage I intermediate-risk endometrial cancer (SELECT, SEntinel Lymph node Endometrial Cancer Trial). Int J Gynecol Cancer. 2020 Oct;30(10):1627-1632. doi: 10.1136/ijgc-2020-001698. Epub 2020 Jul 22.(PubMed)