Status:
COMPLETED
De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer
Lead Sponsor:
Washington University School of Medicine
Conditions:
Endometrial Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with ute...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04386993
Start Date
July 7 2020
End Date
October 13 2025
Last Update
October 20 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110