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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiation Treatment (Dose-Finding Arm) | Experimental | All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer). |
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| Expansion Cohort (Efficacy Arm) | Experimental | Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | 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 | 3-5 weeks (end of treament) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month post radiation |
| Change in gastrointestinal toxicity over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Son, MD | Contact | 773-702-6870 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina Son, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Institute, Emory University | Active, not recruiting | Atlanta | Georgia | 30322 | United States | |
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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 |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Clinical Follow-Up and Assessments | Other | 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. |
|
Determined using frequency of reported events of diarrhea and proctitis on the Patient Reported Outcomes (PRO-CTCAE) |
| 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. | 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. | 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. | End of treatment |
| University of Illinois at Chicago (UIC) |
| Recruiting |
| Chicago |
| Illinois |
| 60612 |
| United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| 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 |