Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

NCT04683653 | Recruiting Phase 1

• 1 other identifier: IRB20-1390
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• Change in patient-reported acute urinary side effects

  1 month post radiation

• Change in gastrointestinal toxicity over time

  1 month post radiation

• Overall quality of life after treatment

  2 years post treatment

• Financial Distress of Treatment

  End of treatment

• Treatment Satisfaction

  End of treatment

Study Arms (2)

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).

Radiation: Hypofractionated Radiation

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.

Other: Clinical Follow-Up and Assessments

Interventions

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.

Hypofractionated Radiation Treatment (Dose-Finding Arm)

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.

Expansion Cohort (Efficacy Arm)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (5)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

ACTIVE NOT RECRUITING

University of Illinois at Chicago (UIC)

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Christina Son, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Son, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: January 15, 2021
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): May 22, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (5)