This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less often. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
At each visit, the subject will be evaluated for any signs of their endometrial cancer or symptoms returning (clinical disease recurrence) and any negative side effects associated with their prior radiation treatment. Study participants will also be asked to fill out a survey regarding bowel/urinary habits and quality of life questionnaires (known as the "EPIC questionnaire") during these visits. The data collected during these clinical follow up visits will be used to determine how effective hypofractionated/shortened whole radiation therapy is for treating endometrial cancer.
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGUniversity of Illinois at Chicago (UIC)
Chicago, Illinois, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGHuntsman Cancer Institute
Salt Lake City, Utah, United States
RECRUITINGThe Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)
The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.
Time frame: 3-5 weeks
Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)
Change in quality-of-life experience on the bowel and urinary domains
Time frame: 3-5 weeks (end of treament)
Change in patient-reported acute urinary side effects
Determined using frequency of reported events of urinary frequency, urinary incontinence, and urinary urgency on the Patient Reported Outcomes (PRO-CTCAE)
Time frame: 1 month post radiation
Change in gastrointestinal toxicity over time
Determined using frequency of reported events of diarrhea and proctitis on the Patient Reported Outcomes (PRO-CTCAE)
Time frame: 1 month post radiation
Overall quality of life after treatment
Total quality of life score from the Functional Assessment of Cancer Therapy (FACT)-General questionnaire will be calculated. A higher score indicates better quality of life.
Time frame: 2 years post treatment
Financial Distress of Treatment
Change in reported financial distress in patients as reported on the Functional Assessment of Chronic Illness Therapy- COST (FACIT-COST) questionnaire. Higher scores on scale of 0-5 indicates better financial wellbeing.
Time frame: End of treatment
Treatment Satisfaction
We will characterize the measure of regret experienced in the study patients over time as reported on the Decision Regret Scale questionnaire. Higher scores on scale of 0-100 indicates high regret.
Time frame: End of treatment
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