Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
NCT ID: NCT04683653
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2021-01-15
2027-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Hypofractionated Radiation Treatment (Dose-Finding Arm)
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).
Hypofractionated 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.
Expansion Cohort (Efficacy Arm)
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.
Clinical Follow-Up and Assessments
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.
Interventions
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Hypofractionated 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.
Clinical Follow-Up and Assessments
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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO).
* Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
* Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
* Eastern Cooperative Oncology Group (ECOG) PS≤ 2
* Able to provide informed consent and willingness to sign an approved consent form
Exclusion Criteria
* Concurrent (or other) chemotherapy occurring at the time of study.
* Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
* History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
* Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
* Recommendation to undergo para-aortic nodal irradiation.
18 Years
FEMALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Christina Son, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Illinois at Chicago (UIC)
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Mercedes Carrasquillo
Role: primary
Cancer Intake
Role: primary
Rauda Alicia Cordova
Role: primary
Geena Mathew
Role: backup
Rachel Kingsford
Role: primary
David Samuel
Role: backup
Other Identifiers
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IRB20-1390
Identifier Type: -
Identifier Source: org_study_id