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Radiation

Hypofractionated Radiation Therapy for Breast Cancer

N/A
Waitlist Available
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%
Must not have
Diagnosis of lupus
Diagnosis of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post end of treatment (eot)
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I agree to use effective birth control or abstain from sex during and for 90 days after the study.
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I can perform most of my daily activities without assistance.
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My breast cancer is at stage II or III, with affected lymph nodes, or it is a large tumor without affected nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with lupus.
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My cancer has spread to other parts of my body.
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I have been diagnosed with active dermatomyositis.
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I have been diagnosed with scleroderma.
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I have been diagnosed with inflammatory breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post end of treatment (eot)
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post end of treatment (eot) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lymphedema Rate
Secondary study objectives
Cosmetic (Breast) Outcome
Local Recurrence
Quality of Life
+1 more

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802
80%
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~160

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,053 Total Patients Enrolled
22 Trials studying Breast Cancer
3,988 Patients Enrolled for Breast Cancer
Shane Stecklein, MD, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT02958774 — N/A
Breast Cancer Research Study Groups: Hypofractionated Radiation Therapy
Breast Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT02958774 — N/A
Hypofractionated Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02958774 — N/A
~48 spots leftby Dec 2025
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