De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    25
  • sponsor
    Washington University School of Medicine
Updated on 22 March 2021
cancer
hysterectomy
neutrophil count
adenocarcinoma
carcinosarcoma
endometrial adenocarcinoma

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 uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate < 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.

Details
Condition Endometrial Carcinoma, Uterine Cancer, Endometrial Cancer
Treatment Intensity Modulated Radiation Therapy
Clinical Study IdentifierNCT04386993
SponsorWashington University School of Medicine
Last Modified on22 March 2021

Eligibility

Yes No Not Sure

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, 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
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