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Hypofractionated Radiation Therapy in Treating Patients with Stage II-III Breast Cancer Undergoing Total Nodal Irradiation

Trial Status: Active

This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage II-III breast cancer undergoing total nodal irradiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Inclusion Criteria

  • Ability to understand and the willingness to sign a written informed consent
  • Karnofsky performance status 50% to 100%
  • Diagnosis of stage IB to III node-positive breast cancer; NOTE: Stages include: T4a-cNany, TxN2, TxN1, T3N0 * For patients with T1N1 disease, ONE of the following criteria is strongly suggested, but not required: ** Grade 3 ** =< 60 years of age at time of screening for this study ** Lymphovascular space invasion (LVSI) ** 2 or more lymph nodes positive ** If only 1 lymph node positive, measures 5 mm or greater ** Hormone-negative disease ** Positive lymph nodes after chemotherapy ** Extracapsular extension ** Close or positive margin *** For patients with T3N0 disease, one of the following high risk features is strongly suggested, but not required: * Triple negative disease * Status post neoadjuvant chemotherapy NOTE: Patients with evidence of infraclavicular (axillary level III), supraclavicular or internal mammary adenopathy on ultrasound or magnetic resonance imaging (MRI) imaging after diagnosis will be included ONLY if this disease can be included in the initial treatment field and supplemented with a 10 Gy boost at the time of mastectomy flap boost
  • 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 occurs last
  • Women of child-bearing potential 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; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

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 active lupus
  • Diagnosis of active dermatomyositis
  • Diagnosis of metastatic disease
  • Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600

Missouri

Kansas City
North Kansas City Hospital
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600
The University of Kansas Cancer Center-South
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600
University of Kansas Cancer Center - North
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE
Contact: Shane Richard Stecklein
Phone: 913-588-3600

PRIMARY OBJECTIVE:

I. To determine lymphedema rates in patients requiring RNI who receive hypofractionated radiation.

SECONDARY OBJECTIVES:

I. To determine local control benefit in patients receiving hypofractionated radiation for breast cancer requiring regional nodal irradiation.

II. To determine whether cosmetic outcomes at short term and long term follow-up for patients receiving radiation to the regional nodal regions.

III. To determine changes in quality of life, using the FACT-B+4 breast quality of life questionnaire, for patients undergoing hypofractionated radiation.

OUTLINE:

Beginning 3-12 weeks after surgery or chemotherapy, patients undergo hypofractionated radiation therapy daily (QD) for 4 weeks.

After completion of study treatment, patients are followed up between 14 and 90 days and at 6 and 18 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
University of Kansas Cancer Center

Principal Investigator
Shane Richard Stecklein

  • Primary ID STUDY00141304
  • Secondary IDs NCI-2017-02001
  • Clinicaltrials.gov ID NCT02958774