Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONHypofractionated Radiation Therapy
Chest/Breast 4005 centigray (cGy)/15 fractions/267 cGy daily Regional nodes 4005 cGy/15 fractions/267 cGy daily 1000 cGy boost to lumpectomy/scar/undissected nodes 200 cGy daily
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphedema Rate | One year post end of treatment (EOT) | Defined as a 10% increase in arm circumference from pre-treatment (baseline) arm circumference measurement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Recurrence | 12 months post-EOT | Defined as biopsy proven recurrence of breast cancer involving the chest wall, breast, axilla, internal mammary or supraclavicular nodes |
| Cosmetic (Breast) Outcome | 12 months post-EOT | Measured using the Breast Q™ Assessment questionnaire |
| Quality of Life | After enrollment but prior to CT simulation; 14-90 days post-EOT; 12 months post-EOT | Measured using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) questionnaire |
| Range of Motion (Upper Extremities) | 14-90 days post-EOT; 6 months post-EOT; 12 months post-EOT | Percent reduction in referrals to physical therapy for impaired range of movement post-EOT |
Countries
United States
Outcome results
None listed