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

STATUS

Recruiting
participants needed

25
sponsor

Washington University School of Medicine

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Updated on 19 February 2024

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cancer

hysterectomy

absolute neutrophil count

neutrophil count

adenocarcinoma

pelvic radiation

carcinosarcoma

endometrial adenocarcinoma

endometrial cancer

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, endometrial cancer, Uterine Cancer, Uterine Cancer, endometrial cancer
Age	18years - 100years
Treatment	Intensity modulated radiation therapy
Clinical Study Identifier	NCT04386993
Sponsor	Washington University School of Medicine
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically or cytologically confirmed stage IIIA-IV endometrial cancer, or any stage with uterine serous 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 K/cumm
	Absolute neutrophil count 500 K/cumm
	Platelets 50,000 K/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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Study Definition

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