Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer

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).

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Radiation: Hypofractionated Radiation; Other: Clinical Follow-Up and Assessments

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Christina Son, MD; Phone Number: 773-702-6870; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Active, not recruiting
      • Winship Cancer Institute, Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Cancer Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago (UIC)
      • Principal Investigator: Christina Son
      • Contact: Mercedes Carrasquillo; Phone Number: 312-413-1902; Email: micarras@uic.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Rauda Alicia Cordova; Phone Number: 713-563-8466; Email: racordova@mdanderson.org
      • Contact: Geena Mathew; Phone Number: 713-792-4594; Email: geenag@mdanderson.org
      • Principal Investigator: Anuja Jhingran,, MD
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute
      • Contact: Rachel Kingsford; Phone Number: 801-585-0115; Email: rachel.kingsford@hci.utah.edu
      • Contact: David Samuel; Phone Number: 801-587-4713; Email: David.Samuel@hci.utah.edu
      • Principal Investigator: Gita Suneja, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Radiation: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Christina Son, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): May 22, 2027

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Therapeutics; Radiotherapy; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiation Dose Hypofractionation
• Other Study ID Numbers: IRB20-1390

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No