A Study to Assess Endometrial Cancer Recurrence in Patients After 36 Months
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-010248
NCT ID: NCT04291612
Sponsor Protocol Number: 20-067 A(6)
About this study
The purpose of this study is to assess the 36-month incidence of pelvic/non-vaginal recurrence among patients with surgical stage I intermediate-risk endometrial cancer.
Eligible patients presenting with apparent uterine confined grade 1, 2, or 3 endometrioid endometrial cancer will undergo standard-of-care primary surgical treatment with a cervical injection of indocyanine green (ICG) dye for SLN mapping, a total hysterectomy, removal of the adnexae and staging with sentinel node mapping and pelvic washings.
The final assessment for inclusion in the follow-up part of the study will be determined from the results of the final hysterectomy and staging pathology report to ensure bilaterally negative pelvic sentinel nodes and a surgical stage I endometrioid endometrial cancer grade 1 or 2 with 50% or more uterine myoinvasion or grade 3 with less than 50% uterine myoinvasion. Women meeting this criteria will comprise the study cohort and be followed for three years.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - Preop:
- 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 pelvic +/- abdominal 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
Exclusion Criteria - Preop:
- Extrauterine disease, 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.
Inclusion Criteria - Postop:
- Hysterectomy.
- Bilateral salpingo-oophorectomy, unless already previously performed.
- Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy).
- Final pathology must show 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).
- Final pathology must show negative pelvic peritoneal cytology.
- Adjuvant treatment as recommended by the multidisciplinary team must be
as follows:
o No adjuvant treatment; or
o Intravaginal radiation only.
Exclusion Criteria - Postop:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available