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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 previously 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

Locations
United States
Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital
RECRUITING
Hartford
Florida
Miami Cancer Institute Baptist Health South Florida
RECRUITING
Miami
University of Miami (Data Collection Only)
NOT_YET_RECRUITING
Miami
ADVENTHEALTH (Data collection only)
RECRUITING
Orlando
Minnesota
Mayo Clinic (Data Collection and Data Analysis)
RECRUITING
Rochester
New Jersey
Memorial Sloan Kettering Basking Ridge (All protocol activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All protocol activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All protocol activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITING
Rockville Centre
Pennsylvania
Lehigh Valley Health Network
RECRUITING
Allentown
Other Locations
Italy
OSPEDALE MICHELE E PIETRO (Data Collection Only)
RECRUITING
Ferrera
UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)
NOT_YET_RECRUITING
Milan
FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)
NOT_YET_RECRUITING
Roma
L'Azienda Sanitaria Universitaria Friuli Centrale
RECRUITING
Udine
Norway
OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
NOT_YET_RECRUITING
Oslo
Contact Information
Primary
Nadeem Abu-Rustum, MD
abu-rusn@mskcc.org
212-639-7051
Backup
Mario Leitao, MD
leitaom@mskcc.org
212-639-3987
Time Frame
Start Date: 2020-02-26
Estimated Completion Date: 2026-02-26
Participants
Target number of participants: 1400
Treatments
Part 1
Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.
Part 2
Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov