Hypofractionated Regional Nodal Irradiation in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Number of participants with chronic arm lymphedema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes
Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
干预措施: hypofractionated radiation (Radiation)
Group 2: axillary lymph node dissection
Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
干预措施: hypofractionated radiation (Radiation)
结局指标
主要结局
Number of participants with chronic arm lymphedema
时间窗: 3 years post radiation therapy
Chronic arm lymphedema will be assessed at the 3 year follow up. Determination of chronic lymphedema will be based on measurements of arm circumference prior to radiation simulation and through the 3 year follow up visit. Clinically significant lymphedema is defined as a 10% or greater difference in ipsilateral arm, forearm, or both, compared to the contralateral side.
次要结局
- Overall survival (months)(3 years)
- Progress-free survival (months)(3 years)
- Participant Perception of Quality of Life(3 years)
- Number of participants with recurrence of cancer(3 years post radiation therapy)
- Number acute toxicities(6 months)
- Number of chronic toxicities(1 year)
- Cosmetic Outcome(3 years)
- Lymphedema requiring intervention(3 years)
研究者
Joshua Dilworth
MD, Radiation Oncology
Corewell Health East