Trial Title:
HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER
NCT ID:
NCT06443359
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
lymphedema
hypofractionated
radiation therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
hypofractionated radiation
Description:
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.
Arm group label:
Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes
Arm group label:
Group 2: axillary lymph node dissection
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Corewell Health William Beaumont University Hospital
Address:
City:
Dearborn
Zip:
48124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mary Martin, RN
Phone:
248-551-0439
Email:
mary.martin@corewellhealth.org
Facility:
Name:
Corewell Health William Beaumont University Hospital
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mary Martin
Phone:
248-551-0439
Email:
mary.martin@corewellhealth.org
Facility:
Name:
Corewell Health William Beaumont University Hospital
Address:
City:
Troy
Zip:
48085
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mary Martin, RN
Phone:
248-551-0439
Email:
mary.martin@corewellhealth.org
Start date:
November 13, 2018
Completion date:
May 2025
Lead sponsor:
Agency:
William Beaumont Hospitals
Agency class:
Other
Source:
William Beaumont Hospitals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06443359
