NCT04291612 Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
| NCT ID | NCT04291612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Endometrial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,715 participants |
| Start Date | 2020-02-26 |
| Primary Completion | 2027-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,715 participants in total. It began in 2020-02-26 with a primary completion date of 2027-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Nadeem Abu-Rustum, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04291612 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04291612 currently recruiting?
Yes, NCT04291612 is actively recruiting participants. Contact the research team at abu-rusn@mskcc.org for enrollment information.
Where is the NCT04291612 trial being conducted?
This trial is being conducted at Hartford, United States, Miami, United States, Miami, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT04291612 clinical trial?
NCT04291612 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Nadeem Abu-Rustum, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 1,715 participants.
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