observational study of women with endometrial cancer who receive the standard treatment for their disease

Conditions: Endometrial Cancer; Endometrioid Adenocarcinoma; Endometrial Cancer Stage I

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 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

Keywords: endometrial cancer endometrioid adenocarcinoma 20-067 memorial sloan kettering cancer center