Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 12
- 主要终点
- Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
研究概览
简要总结
This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female gender
- •Age ≥18 years
- •An invasive primary breast cancer of any histology arising from breast parenchyma
- •Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection
- •Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is
- •Patient signed study-specific consent form.
排除标准
- •Patients with distant metastasis.
- •Patients who are pregnant or breastfeeding.
- •Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
- •Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.
- •Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.
- •Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
- •Primary breast cancer is a lymphoma or sarcoma histology.
- •Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.
- •Patients requiring radiation to the bilateral breasts.
结局指标
主要结局
Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
时间窗: 5 weeks
The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.
次要结局
- Number of Participants Evaluated for Acute and Late Cutaneous Toxicity(5-7 months following the completion of radiation therapy)
- Number of Participants Evaluated for Late Subcutaneous Fibrosis(5-7 months following the completion of radiation therapy)
- Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score(6 months post radiation therapy)
- Mean FEV1 at Baseline(Baseline)
- Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)(6 months post radiation therapy)
- Median Follow-up Period(up to 82 months post-radiation therapy)
- Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)(6 months post radiation therapy)