Hypofractionated Regional Nodal Irradiation in Breast Cancer (NCT06443359) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Hypofractionated Regional Nodal Irradiation in Breast Cancer
United States56 participantsStarted 2018-11-13
Plain-language summary
This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. After enrollment, participants will be stratified into 2 Groups based on the extent of axillary surgery. Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female
* Age ≥ 18 years old
* Life expectancy of \>5 years
* ECOG (Zubrod) performance status 0-1
* Histologically confirmed invasive carcinoma of the breast, including ductal, lobular, mammary, medullary, and tubular histologies
* Clinical T stage of cT0, cT1, cT2, or cT3
* Clinical N stage of cN0, cN1, or cN2a
* Clinical M stage of cM0Definitive surgery must be performed (either partial mastectomy or mastectomy without immediate reconstruction) with negative surgical margins (defined as no invasive tumor or DCIS on ink).
* Must have pathologic T stage of pT1, pT2, or pT3, or if receiving neoadjuvant chemotherapy, ypT0, ypTis, ypT1, ypT2, or ypT3
* Pathologic N stage of pN0, pN1, pN2a, or pN3a, or if receiving neoadjuvant chemotherapy, ypN0,ypN1, ypN2, or ypN3a) NOTE: any patient with clinically involved but undissected lymph nodes that would require a radiation boost will not be eligible.
* The radiation oncologist is planning to treat the breast/chest wall and ipsilateral regional lymphatics (including the axillary, supraclavicular, and internal mammary chains)
* Patient is able to understand and willing to sign an IRB approved written informed consent document
* All dosimetric constraints outlined in protocol section 3.5 can be met
Exclusion Criteria:
* Clinical or pathologic T4 disease, including inflammatory breast cancer
* Clinical N stage of cN2b, cN3 disease, pathologic N stage of pN2b, pN3b, or pN3c disease, or if receiving neoadjuvant chemo…
What they're measuring
1
Number of participants with chronic arm lymphedema