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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04291612
Ethics application status
Date submitted
27/02/2020
Date registered
2/03/2020
Date last updated
24/05/2024

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:
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Screening

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
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 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 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

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 previously 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
26/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/02/2025
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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/study/NCT04291612
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Nadeem Abu-Rustum, MD
Address 0 0
Memorial Sloan Kettering Cancer Center
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
[email protected]
Contact person for scientific queries



Summary Results

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