Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
研究概览
简要总结
This phase II trial studies the shoulder morbidity in patients with lymph-node positive breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal radiation therapy. Intensity modulated radiation therapy may cause less shoulder/arm morbidity in patients with lymph-node positive breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if intensity modulated radiation therapy (IMRT) reduces average 1-year patient-reported shoulder/arm morbidity in women receiving regional nodal irradiation (RNI) for lymph-node positive breast cancer as compared to historical data.
SECONDARY OBJECTIVES:
I. To measure patient-reported shoulder/arm morbidity in women receiving RNI with 3-dimensional conformal radiation therapy (3DCRT) for lymph-node positive breast cancer.
II. To measure change in shoulder range of motion in women receiving RNI. III. To measures rates of ipsilateral upper extremity lymphedema in women receiving RNI.
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
- •Pathologically proven diagnosis of breast cancer
- •Patients that receive neoadjuvant systemic therapy (chemotherapy, anti-HER2 therapy, or endocrine therapy) are eligible
- •History/physical examination within 60 days prior to study entry
- •Patients who have undergone either a lumpectomy or mastectomy are eligible
- •Patients that have undergone any type of breast reconstruction are eligible
- •The interval between the date of last surgery or chemotherapy and registration must be =< 84 days
- •Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of radiation therapy
- •Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- •Patients must provide study specific informed consent prior to study entry
排除标准
- •Clinical or radiologic evidence of distant metastases
- •Patients with known unresected disease in the axillary apex or supraclavicular fossa
- •Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
- •Prior surgery to the ipsilateral shoulder for any condition
- •Baseline impaired mobility of the ipsilateral shoulder from a condition not related to the breast cancer surgery as determined by the treating physician
- •Non-epithelial breast malignancies such as sarcoma/lymphoma
- •Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- •Medical, psychiatric, or other conditions that would prevent the patient from receiving the protocol therapy or providing informed consent
- •Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
研究组 & 干预措施
Arm A (IMRT)
Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm B (3DCRT)
Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
结局指标
主要结局
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
时间窗: At 1 year
DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity. The full scale range is 0-100.
次要结局
- Measure rates of upper extremity lymphedema using arm circumference with a tape measure(At baseline, 1 month, 6 months and 12 months post-radiation)
- Measure rates of upper extremity lymphedema using a perometer(At baseline, 1 month, 6 months and 12 months post-radiation)
- Distant metastases in patients treated with IMRT(At 5 years)
- Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH(Up to 5 years)
- Rates of loco-regional control in patients treated with IMRT(At 5 years)
- Changes in shoulder range of motion for flexion, abduction, internal and external rotation using a goniometer as defined by the American Academy of Orthopedic Surgeons(At baseline, 1 month, 6 months and 12 months post-radiation)
- Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT(Up to 5 years)
- Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT(Up to 5 years)
- Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)(At 1 year)
- Overall survival in patients treated with IMRT(Up to 5 years)
研究者
Sasha Beyer
Principal Investigator
Ohio State University Comprehensive Cancer Center