Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

This study is testing a shorter way to give radiation treatment, called Hypofractionated Radiation, for women with endometrial cancer. The goal is to see if this shorter treatment is safe and to find the best dose. You might be able to join if you are a woman aged 18 or older with endometrial cancer that has been treated with surgery and has not spread. The study will look at the highest safe dose of this shorter radiation and how it affects stomach and bowel side effects. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 100 participants. It is testing a new way to give radiation treatment.
What's involved
You would receive Hypofractionated Radiation treatment. After treatment, you would have follow-up visits to check for cancer returning and any side effects.
Compensation
Not stated in the trial record.
Follow-up
You will be evaluated for signs of cancer returning and side effects during follow-up visits, with primary endpoints measured at 3-5 weeks after treatment.

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NCT04683653

Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Chicago
~100 participants
Updated 2025-12-29 on ClinicalTrials.gov
What's tested:Hypofractionated RadiationClinical Follow-Up and Assessments

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)
Measured over 3-5 weeks
+1 more outcome measured
Endometrial Cancer
5 sites across 4 states
Illinois2
Georgia1
Texas1
Utah1
  • Christina Son, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

Diagnosis of primary cervical cancer or uterine cancer of any histology
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

Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
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.
  • The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)3-5 weeks

    The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.

  • Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)3-5 weeks (end of treament)

    Change in quality-of-life experience on the bowel and urinary domains