Kansas City, Kansas 66160

  • Breast Cancer

Purpose:

The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.


Study summary:

Participants with stage II or stage III node-positive breast cancer, or T3N0 node-negative will receive hypofractionated radiation for 4 weeks. We hypothesize that patients receiving a shorter course of radiation will have reduced lymphedema. Lymphedema is diagnosed when the patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm circumference measurement. Secondary endpoints will address the effectiveness, quality of life, and side effect profile of a shortened course of treatment.


Criteria:

Inclusion Criteria: - Karnofsky Performance Status 50% - 100% - Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include: T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer. - For patients with TxN1 disease, one of the following criteria must be met: Grade 3; ≤ 45 years of age at time of screening for this study; extensive Lymphovascular Space Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension - Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last. - 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. Exclusion Criteria: - Diagnosis of inflammatory breast cancer - Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more) - Diagnosis of scleroderma - Diagnosis of lupus - Diagnosis of active dermatomyositis - Diagnosis of metastatic disease - Pregnant or nursing


NCT ID:

NCT02958774


Primary Contact:

Principal Investigator
Shane Stecklein, MD, PhD
University of Kansas Medical Center

Shane Stecklein, MD, PhD
Phone: 9135885000
Email: sstecklein@kumc.edu


Backup Contact:

Email: mtennapel@kumc.edu
Mindi J TenNapel, PhD
Phone: 9135885000


Location Contact:

Kansas City, Kansas 66160
United States

Shane Stecklein, MD, PhD
Phone: 913-588-5000
Email: sstecklein@kumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.