DeCRESCEndo: De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMRT -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. |
Radiation: Intensity modulated radiation therapy
Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events [From start of radiation until 2 weeks after completion of radiation (approximately 4 weeks)]
- Incidence of late hematologic, gastrointestinal, and genitourinary adverse events [From 2 weeks after completion of radiation until 12 months (approximately 50 weeks)]
Secondary Outcome Measures
- Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE [Baseline, 2 weeks, and 3 months post-completion of radiation]
PRO-CTCAE responses are scored from 0 to 4 with 0=Never/Not at all/None and 4=Frequently/Very Much/Very Severe/Almost Constantly Scores for each attribute (frequency, severity and/or interference) will be presented descriptively
- 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]
Bladder has 7 questions and bowel has 9 questions The response for each item is standardized to a 0 to 100 scale The standardized values will be averaged for all items within a group to create the summary or subscale score.
- Change in quality of life as measured by FACT-En [Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation]
Questionnaire asking questions about physical well-being, social/family well-being, emotional well-being, functional well-being, and other additional concerns. Answers range from 0 = not at all to 4 = very much. Questions are phrased so that higher numbers indicate a better health state, Scoring is performed through a simple sum of item scores. Each subscale is scored, and a total score is obtained by adding each of the subscale scores.
- Locoregional control [Up to 12 months post-completion of radiation]
-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.
- Distant control [Up to 12 months post-completion of radiation]
-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.
- Disease-free survival [Up to 12 months post-completion of radiation]
-Disease-free survival is defined as no evidence of endometrial cancer recurrence or death
- Overall survival [Up to 12 months post-completion of radiation]
-Number of participants alive at the time of completion of follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
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At least 18 years of age.
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ECOG performance status ≤ 2
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Minimal bone marrow and organ function as defined below:
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Leukocytes ≥ 1,000 cumm
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Absolute neutrophil count ≥ 500 cumm
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Platelets ≥ 50,000 cumm
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Hemoglobin ≥ 7g/dL
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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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Prior radiation to the pelvis.
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Currently receiving any investigational agents.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Stephanie Markovina, M.D., Ph.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 202004237