NCT07612254尚未招募1 期
REPEAT: RE-irradiation With a Partial brEast, Accelerated Technique: A Single-Center, Multi-site, Prospective, Phase I/II Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
- •Patients must have received prior radiotherapy to the breast
- •Patients must have an intact, involved breast.
- •Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.
- •Grade 1-2 disease
- •ER-positive histology
- •Tumor size up to 2 cm
- •Patient's age 40 or older
- •Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
- •Patients must have a lumpectomy cavity that can be delineated on CT scan.
- •Patients who are able to provide informed consent.
- •Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
- •Females of childbearing potential must not be pregnant and not lactating and willing to use medically acceptable form of contraception during radiation therapy.
排除标准
- •Patients who meet any of the criteria below may NOT participate in this study:
- •Patients who have not received prior radiotherapy to the ipsilateral breast.
- •Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation, including those who meet criteria for conditionally recommended, conditionally not recommended, and not recommended for partial breast irradiation.
- •Patients who are < 40 years of age.
- •Patients with breast implants or other breast reconstruction.
- •Patients who received a prior course of aPBI or breast brachytherapy in the ipsilateral breast.
- •Patients who are actively receiving treatment or within 1 year of treatment from another malignancy, excluding non-melanoma skin cancers.
- •Patients who are pregnant.
- •Patients who are unable to provide informed consent.
- •Patients who decline participation in the study.
- •Patients with active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash are excluded.
研究者
Lesley A. Jarvis
Physician Radiation Oncology
Dartmouth-Hitchcock Medical Center
研究点 (1)
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