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Radiation
Hypofractionated Radiotherapy for Endometrial Cancer
N/A
Recruiting
Led By Christina Son, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after last dose of radiation treatment.
Awards & highlights
Study Summary
This trial will test if a shorter, more intense course of radiation is safe and effective for treating endometrial cancer.
Who is the study for?
This trial is for women over 18 with Stage I-III endometrial cancer who've had a hysterectomy and show no signs of remaining cancer or distant metastases. It's not for those receiving concurrent chemotherapy, with bowel issues, prior pelvic radiation, unresolved chemo side effects, or connective tissue disorders.Check my eligibility
What is being tested?
The study tests if a shorter course of higher-dose pelvic radiation (hypofractionation) is safe and effective in treating endometrial cancer compared to the standard longer treatment. The goal is to find the best dose that's both tolerable and similar in effectiveness to conventional therapy.See study design
What are the potential side effects?
Potential side effects may include skin irritation at the treatment site, fatigue, digestive problems like diarrhea or nausea due to increased daily doses of radiation even though overall treatment time is reduced.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is endometrial cancer with a specific cell type.
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I am 18 years old or older.
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My cancer was diagnosed as Stage I-III by FIGO standards.
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I had surgery to remove my uterus without any visible cancer left and may or may not have had my lymph nodes checked.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after last dose of radiation treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after last dose of radiation treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment
Secondary outcome measures
Rate of Pelvic Control 2 Years Post Radiation
Toxicity Determined by Reported Adverse Events for Hypofractionated Whole Pelvic Radiation Treatment
Trial Design
2Treatment groups
Experimental Treatment
Group I: Hypofractionated Radiation Treatment (Dose-Finding Arm)Experimental Treatment1 Intervention
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).
Group II: Expansion Cohort (Efficacy Arm)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,003 Previous Clinical Trials
819,709 Total Patients Enrolled
2 Trials studying Endometrial Cancer
45 Patients Enrolled for Endometrial Cancer
Christina Son, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis is endometrial cancer with a specific cell type.I am 18 years old or older.I have a history of bowel issues or connective tissue disorder needing ongoing treatment, or I've had pelvic radiation.I am not currently undergoing any chemotherapy.I am advised to have pelvic radiotherapy alone, not with chemotherapy.I still have cancer cells after surgery, confirmed by my doctor.My cancer was diagnosed as Stage I-III by FIGO standards.I am recommended to have radiation therapy on the lymph nodes near my aorta.I have ongoing diarrhea or stomach pain from chemotherapy that needs medication.My endometrial cancer has spread to distant parts of my body.I had surgery to remove my uterus without any visible cancer left and may or may not have had my lymph nodes checked.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Radiation Treatment (Dose-Finding Arm)
- Group 2: Expansion Cohort (Efficacy Arm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being enlisted for this experiment?
"Affirmative. According to clinicaltrials.gov, this medical study is still recruiting participants since it was first published on January 15th 2021 and last updated on the 21st of that same month. 40 subjects will be taken from a single center for this experiment."
Answered by AI
Are there any available openings for individuals to participate in this research?
"Affirmative. The clinicaltrials.gov database reveals that this medical research is presently recruiting test subjects, having been first posted on 15th January 2021 and last updated 21st of the same month. 40 patients are required at a single site for enrollment."
Answered by AI
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