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Radiation
Hypofractionated Radiation Therapy for Breast Cancer
N/A
Recruiting
Led By Shane Stecklein, MD, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing potential (WOCP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
Karnofsky Performance Status 50% - 100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post end of treatment (eot)
Awards & highlights
Study Summary
This trial will compare rates of lymphedema in patients receiving different doses of radiation for cancer treatment.
Who is the study for?
This trial is for women with certain stages of breast cancer who may be of child-bearing age and agree to use contraception. They should have had prior surgery or chemotherapy but no radiation in the target area, and their physical condition must allow them to participate actively in daily life.Check my eligibility
What is being tested?
The study is testing hypofractionated radiation therapy compared to conventional radiation, specifically looking at lymphedema rates (swelling due to fluid build-up) among patients needing regional nodal irradiation.See study design
What are the potential side effects?
While not explicitly listed here, side effects of hypofractionated radiation can include skin irritation, fatigue, swelling (lymphedema), and potential long-term changes in breast texture.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use effective birth control or abstain from sex during and for 90 days after the study.
Select...
I can perform most of my daily activities without assistance.
Select...
My breast cancer is at stage II or III, with affected lymph nodes, or it is a large tumor without affected nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year post end of treatment (eot)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post end of treatment (eot)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lymphedema Rate
Secondary outcome measures
Cosmetic (Breast) Outcome
Local Recurrence
Quality of Life
+1 moreSide effects data
From 2022 Phase 2 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hypofractionated Radiation TherapyExperimental Treatment1 Intervention
Daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
168,881 Total Patients Enrolled
22 Trials studying Breast Cancer
4,121 Patients Enrolled for Breast Cancer
Shane Stecklein, MD, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for over 5 years, except for skin cancer.I have a specific type of cancer with certain high-risk features.I agree to use effective birth control or abstain from sex during and for 90 days after the study.I have been diagnosed with lupus.My cancer has spread to other parts of my body.I can perform most of my daily activities without assistance.I have been diagnosed with active dermatomyositis.I have been diagnosed with scleroderma.My breast cancer is at stage II or III, with affected lymph nodes, or it is a large tumor without affected nodes.I've had surgery and chemotherapy but no radiation to my breast or chest area yet.I have been diagnosed with inflammatory breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Radiation Therapy
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 individuals have been accepted to participate in this investigation?
"Affirmative. As per the data on clinicaltrials.gov, this research is currently calling for participants to join their ranks. Accounting for its first post date of October 23rd 2017 and most recent edit made April 14th 2021, 389 individuals are expected to be recruited at a single medical site."
Answered by AI
Has recruitment for this research project been closed off?
"Clinicaltrials.gov notes that this investigation is actively seeking participants, the original posting of which was made on October 23rd 2017 and last updated on April 14th 2021."
Answered by AI
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