Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04386993
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology.
* Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Minimal bone marrow and organ function as defined below:
* Leukocytes ≥ 1,000 cumm
* Absolute neutrophil count ≥ 500 cumm
* Platelets ≥ 50,000 cumm
* Hemoglobin ≥ 7g/dL
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* Prior radiation to the pelvis.
* Currently receiving any investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
* Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04386993
Study Brief:
Protocol Section:
NCT04386993