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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04291612




Registration number
NCT04291612
Ethics application status
Date submitted
27/02/2020
Date registered
2/03/2020
Date last updated
24/11/2020

Titles & IDs
Public title
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
Scientific title
SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
Secondary ID [1] 0 0
20-067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Endometrioid Adenocarcinoma 0 0
Endometrial Cancer Stage I 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Physical exam

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)


Other interventions: Physical 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of pelvic/non-vaginal recurrence at 36 months - Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
Timepoint [1] 0 0
36 months

Eligibility
Key inclusion criteria
Part I

- ECOG performance status 0-1 or KPS = 70%

- Age = 18 years

- Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation
and curettage confirmed at the enrolling institution

- 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

- 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

Part 1
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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

Part 2 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 (part 2 n=182)

A patient will be enrolled in the study cohort (part 2) if all the following criteria are
met:

- At surgery, the patient must undergo:

- Hysterectomy with removal of the adnexa

- 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)

- Negative pelvic peritoneal cytology

- Adjuvant treatment as recommended by the multidisciplinary team must be as follows:

- No adjuvant treatment, or

- Intravaginal radiation only

Part 2 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

- 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Czechia
State/province [9] 0 0
Prague

Funding & Sponsors
Primary sponsor type
Other
Name
Memorial Sloan Kettering Cancer Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04291612
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nadeem Abu-Rustum, MD
Address 0 0
Country 0 0
Phone 0 0
212-639-7051
Fax 0 0
Email 0 0
abu-rusn@mskcc.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04291612