RecruitingNCT04291612

Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

1,715 participants

Start Date

Feb 26, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria22

  • 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
  • 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

Exclusion Criteria15

  • 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
  • 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

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.


Locations(19)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

University of Miami (Data Collection Only)

Miami, Florida, United States

Miami Cancer Institute Baptist Health South Florida

Miami, Florida, United States

ADVENTHEALTH (Data collection only)

Orlando, Florida, United States

Mayo Clinic (Data Collection and Data Analysis)

Rochester, Minnesota, United States

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Charles University and General University Hospital (Data Collection Only)

Prague, Czechia

OSPEDALE MICHELE E PIETRO (Data Collection Only)

Ferrera, Italy

UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)

Milan, Italy

FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)

Roma, Italy

L'Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)

Oslo, Norway

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NCT04291612


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