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Hypofractionated Radiation Therapy for Endometrial Cancer
N/A
Recruiting
Led By Teresa Meier, MD
Research Sponsored by Teresa Meier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years.
ECOG performance status ≤2 (Karnofsky ≥60%).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing whether a lower dose of radiation therapy spread out over a longer period of time is as effective at treating endometrial cancer as the standard higher dose given in a shorter timeframe.
Who is the study for?
This trial is for adults over 18 with stage I, II, or III endometrial cancer who've had a hysterectomy and possibly lymph node removal. It's suitable for those needing pelvic radiation but not vaginal cuff brachytherapy due to anatomy or higher risk of nodal recurrence. Participants must be in good general health (ECOG ≤2) and able to consent.Check my eligibility
What is being tested?
The study tests hypofractionated whole pelvis radiation therapy as an additional treatment after surgery for endometrial cancer patients. The goal is to see if this type of targeted radiation can effectively treat the area around where the tumor was located.See study design
What are the potential side effects?
While specific side effects are not listed, generally, pelvic radiation can cause fatigue, skin irritation in treated areas, digestive issues like diarrhea or discomfort during bowel movements, bladder irritation leading to urinary urgency or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I have had surgery to remove my uterus, both ovaries, and fallopian tubes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose per fraction (MTDF) of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer through CTCAE data and gastrointestinal PRO-CTCAE data.
Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE.
Secondary outcome measures
Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.
Patient compliance with hypofractionated WPRT, as defined by how many patients are able to complete WPRT without a break in treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hypofractionated Whole-Pelvis RadiotherapyExperimental Treatment1 Intervention
Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx
Find a Location
Who is running the clinical trial?
Teresa MeierLead Sponsor
Teresa Meier, MDPrincipal Investigator - University of Cincinnati
University of Cincinnati Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Inflammatory Bowel Disease.I have active disease in the nodes around my aorta confirmed by surgery.I have had pelvic radiotherapy before.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.My surgery removed all visible cancer, confirmed by my doctor or imaging.You are not currently taking any experimental medications. If you have taken experimental medications in the past but are not currently taking them, the decision to include you in the study will be made by the principal investigator.I have stage I, II, or III endometrial cancer and need pelvic radiation as advised by my oncologist.I can take care of myself but might not be able to do heavy physical work.I have another cancer type, but it won't affect this cancer treatment's safety or results.I have had surgery to remove my uterus, both ovaries, and fallopian tubes.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Whole-Pelvis Radiotherapy
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.
Are there currently any vacancies for participants in this research?
"Clinicaltrials.gov affirms that this trial is seeking participants, commencing on February 4th 2021 and the information was recently updated on February 9th 2021."
Answered by AI
How many test subjects are taking part in this experiment?
"Affirmative, the clinical trial is still recruiting participants as evidenced by its listing on clinicaltrials.gov. It was first posted in February of 2021 and has been updated within this year; it seeks to enroll 15 patients at a single location."
Answered by AI
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