Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their… (NCT04291612) | Clinical Trial Compass
RecruitingNot Applicable
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
United States1,715 participantsStarted 2020-02-26
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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,…
What they're measuring
1
Incidence of pelvic/non-vaginal recurrence at 36 months