Recruiting
Phase 1
Phase 2

Hypofractionation

Sponsor:

University of Chicago

Code:

NCT04683653

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Radiation

Clinical Follow-Up and Assessments

Study Details

Brief summary:

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).

Conditions

Endometrial Cancer

Study ID

NCT04683653

Start date

Jan 15, 2021

Status verified date

Sep, 2026

Completion date

May 22, 2027

Anticipated

Primary completion date

Aug 20, 2026

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

experimental: 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.

Interventions

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.

Primary outcome measure

  • The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1) [ Time Frame: 3-5 weeks ]
  • Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2) [ Time Frame: 3-5 weeks (end of treament) ]

Central Contacts and Locations

Central contacts

Christina Son, MD

773-702-6870cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Illinois at Chicago (UIC)

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Mercedes Carrasquillo

312-413-1902micarras@uic.edu

Principal Investigator:

Christina Son

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Cancer Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Rauda Alicia Cordova

713-563-8466racordova@mdanderson.org

Geena Mathew

713-792-4594geenag@mdanderson.org

Principal Investigator:

Anuja Jhingran,, MD

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

801-585-0115rachel.kingsford@hci.utah.edu

David Samuel

801-587-4713david.samuel@hci.utah.edu

Principal Investigator:

Gita Suneja, MD

More Information

Sponsor

University of Chicago

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-09-03.