Endometrial Cancer
Conditions
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.
Interventions
RADIATIONIntensity modulated radiation therapy
Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Disease-free survival | Up to 12 months post-completion of radiation | -Disease-free survival is defined as survival with no evidence of disease 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 |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed