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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT | Experimental | -Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy. -*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiation therapy | Radiation | Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events | From start of radiation through Day 90 | |
| Incidence of late hematologic, gastrointestinal, and genitourinary adverse events | From Day 91 through month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE |
| Baseline, 2 weeks, and 3 months post-completion of radiation |
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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:
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessika Contreras, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) for individual participant data meta-analysis by investigators whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Proposals may be submitted up to 36 months following article publication.
Please contact Dr. Jessika Contreras.
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26 |
| Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation |
| Change in quality of life as measured by FACT-En |
| Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation |
| Locoregional control | -Locoregional recurrence is defined as histologic or radiographic evidence of cancer in the previously resected site or regional lymph nodes included in the radiated field. | Up to 12 months post-completion of radiation |
| Distant control | -Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field. | Up to 12 months post-completion of radiation |
| Disease-free survival | -Disease-free survival is defined as survival with no evidence of disease recurrence or death | Up to 12 months post-completion of radiation |
| Overall survival | -Number of participants alive at the time of completion of follow-up | Up to 12 months post-completion of radiation |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |