Clinical trial NCT06443359: Hypofractionated Regional Nodal Irradiation in Breast Cancer
Official title: Hypofractionated Regional Nodal Irradiation in Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: lymphedema
hypofractionated
radiation therapy
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. Participants are stratified into 2 Groups based on the extent of axillary surgery after enrollment.

Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes.

Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure) or patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.

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. At baseline consultations, history and physical, lymphedema assessment, toxicity assessment, photographs (optional), patient-reported outcome questionnaire and radiation simulation will be completed. Hypofractionated radiation therapy will be completed weekly through the end of treatment with toxicity assessments. At the 1-2 week follow up, toxicity assessment, photographs (optional) and the patient-reported outcome questionnaire will be completed. At the 3 month, 6 month, 1 year, 2 year and 3 year follow-ups a lymphedema assessment, toxicity assessment, photographs (optional), patient-reported outcome questionnaire and follow up examination will be completed.

All patients will receive a dose of 42.56 Gy in 16 daily fractions to the whole breast or chest wall and regional lymph nodes. A boost dose of 10 or 12.5 Gy in 4 or 5 daily fractions of 2.5 Gy, respectively, will be administered to either the lumpectomy cavity or mastectomy scar, as appropriate. Critical organs will be contoured into the treatment planning such as the heart, left anterior descending artery, ipsilateral lung.

Patients may receive neoadjuvant or adjuvant systemic treatment on this trial. In general, the patient should receive systemic treatment according to the current standard of care at the time of enrollment, taking into account the discretion of the treating medical oncologist.

Expected radiation-related acute adverse events (i.e., those experienced within the first 6 months following treatment) are similar to those with conventionally fractionated radiotherapy and include fatigue and tenderness, pruritus, hyperpigmentation, hypopigmentation, dry desquamation, and moist desquamation of the skin. Potential late effects of radiation include arm lymphedema, shoulder stiffness, fibrosis of normal tissue, telangiectasia, hyperpigmentation, or hypopigmentation of the skin, brachial plexopathy, myositis, rib fracture, pneumonitis, second malignancy, or cardiomyopathy. The participants will be monitored for adverse events during radiotherapy and following radiotherapy.

Eligibility criteria: 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 chemotherapy, ypN2b, ypN3b, or ypN3c disease
* Radiologic evidence of gross residual disease
* History of prior ipsilateral breast cancer (invasive disease or DCIS)
* Active or history of another malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
* Prior history of radiation therapy to the neck, breast, or thorax. Prior radioactive oral iodine is permitted.
* History of active collagen vascular disease including systemic lupus erythematosis, scleroderoma, or dermatomyositis with an elevated CK level
* Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential.
* The patient is a prisoner.

Primary outcomes:
measure: Number of participants with chronic arm lymphedema
timeFrame: 3 years post radiation therapy
Secondary outcomes:
measure: Number of participants with recurrence of cancer
timeFrame: 3 years post radiation therapy
measure: Progress-free survival (months)
timeFrame: 3 years
measure: Overall survival (months)
timeFrame: 3 years
measure: Number acute toxicities
timeFrame: 6 months
measure: Number of chronic toxicities
timeFrame: 1 year
measure: Cosmetic Outcome
timeFrame: 3 years
measure: Lymphedema requiring intervention
timeFrame: 3 years
measure: Participant Perception of Quality of Life
timeFrame: 3 years
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Corewell Health Dearborn Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
city: Troy
country: United States
facility: Corewell Health Beaumont Troy Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Joshua Dilworth, MD
role: PRINCIPAL_INVESTIGATOR
References: