Endometrial Cancer, Endometrioid Adenocarcinoma, Endometrial Cancer Stage I
Conditions
Keywords
Endometrial Cancer, Endometrioid Adenocarcinoma, 20-067, Memorial Sloan Kettering Cancer Center
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.
Interventions
OTHERPhysical 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pelvic/non-vaginal recurrence at 36 months | 36 months | Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination |
Countries
Czechia, Italy, Norway, United States
Contacts
CONTACTNadeem Abu-Rustum, MD
CONTACTMario Leitao, MD
PRINCIPAL_INVESTIGATORNadeem Abu-Rustum, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed