- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683653
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
August 25, 2023 updated by: University of Chicago
Phase I Safety Study of Whole Pelvic Hypofractionated Radiotherapy in Women With 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
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Son, MD
- Phone Number: 773-702-6870
- Email: cancerclinicaltrials@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Contact:
- Cancer Intake
- Phone Number: 855-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of endometrial cancer with any of the following primary histologic types: endometrioid, papillary serous, clear cell, carcinosarcoma, or mixed epithelial histologies.
- Age ≥ 18 years.
- Must have been diagnosed with Stage I-III 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.
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 chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
- Recommendation to undergo para-aortic nodal irradiation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
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 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.
|
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
Time Frame: 3-5 weeks
|
The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.
|
3-5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity Determined by Reported Adverse Events for Hypofractionated Whole Pelvic Radiation Treatment
Time Frame: 3-5 weeks.
|
The acute toxicity profile of hypofractionated radiation therapy using CTCAE v5.0.
CTCAE GU toxicity will be determined using the domains of urinary frequency, urinary incontinence, and urinary urgency (whichever is maximum).
Time point of evaluation is on the last day of radiation.
|
3-5 weeks.
|
Rate of Pelvic Control 2 Years Post Radiation
Time Frame: 2 years after last dose of radiation treatment.
|
The rate of pelvic control at 2 years post-radiation using CTCAE v5.0 domains of diarrhea and proctitis (whichever is maximum).
Study participants will follow 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.
Each follow-up time period will be evaluated for CTCAE GI and GU maximum toxicity.
Crude rates and cumulative incidence of pelvic failure will be calculated.
Pelvic failure is defined as clinical or radiographic evidence of recurrent disease within the irradiated pelvis (pelvic lymph nodes, vaginal cuff, or parametria) as determined by the treating physician(s).
Peritoneal metastases will not be considered a pelvic failure.
|
2 years after last dose of radiation treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina Son, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2021
Primary Completion (Estimated)
May 22, 2025
Study Completion (Estimated)
May 22, 2025
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)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endometrial Cancer
-
Assistance Publique - Hôpitaux de ParisUniversité Montpellier; Ecole d'econmie de Paris (PSE)-Hospinnomics; Université...CompletedEndometrial Cancer Stage I | Endometrial Cancer Stage IIFrance
-
Radboud University Medical CenterMaastricht University Medical Center; Erasmus Medical Center; Catharina Ziekenhuis... and other collaboratorsRecruitingEndometrial Cancer Recurrent | Endometrial Cancer Stage III | Endometrial Cancer Stage IVNetherlands
-
Batman Training and Research HospitalEskisehir Osmangazi UniversityCompletedGynecologic Cancer | Endometrial Cancer Stage
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial CancerChina
-
Novartis PharmaceuticalsCompletedAdvanced Endometrial CancerBelgium, France, Italy, Canada, Spain, Australia, Germany, United States, Japan, Brazil, Singapore, Russian Federation, Poland
-
Samsung Medical CenterRecruitingEndometrial Cancer Stage IKorea, Republic of
-
Duke UniversityDuke Cancer InstituteCompleted
-
Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
-
Rambam Health Care CampusCompletedSerous Papillary Endometrial CancerIsrael
-
Masonic Cancer Center, University of MinnesotaCompletedCervical Cancer | Ovarian Cancer | Uterine Endometrial CancerUnited States
Clinical Trials on Hypofractionated Radiation
-
University of UtahNational Cancer Institute (NCI)RecruitingCervical Carcinoma | Endometrial CarcinomaUnited States
-
University of UtahActive, not recruitingStage 0 Breast Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Invasive Breast Carcinoma | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Ductal Breast Carcinoma In SituUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Prognostic Stage I Breast Cancer AJCC v8 | Prognostic Stage IA Breast Cancer AJCC v8 | Prognostic Stage IB Breast Cancer AJCC v8 | Prognostic Stage IIA Breast Cancer AJCC...United States
-
Ruijin HospitalRecruiting
-
University of Colorado, DenverActive, not recruitingBreast CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8United States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)TerminatedNonsmall Cell Lung Cancer Stage III | Nonsmall Cell Lung Cancer, Stage IIUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingStage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Resectable Soft Tissue Sarcoma | Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Stage IB Soft Tissue Sarcoma of the Trunk and Extremities...United States
-
University of LouisvilleJames Graham Brown Cancer CenterCompletedBreast CancerUnited States
-
Samsung Medical CenterRecruitingRadiotherapy Side EffectKorea, Republic of