Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.
研究概览
简要总结
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 y.o.
- •Histologically proven in situ and invasive ductal or lobular breast recurrence
- •Prior history of whole breast/chest wall radiation therapy
- •Disease span ≤ 3 cm, unifocal
- •No nodal disease (N0)
- •No evidence of metastatic disease (M0)
- •Time from initial BCT should be ≥ 1 year
- •Patients have refused the standard of care of mastectomy
- •Skin distance of ≥ 0.8 cm between applicator and skin
排除标准
- •Multifocal and/or multicenter recurrence
- •N1-3 status: Regional cytological or histologically proven node recurrence
- •M1 status: Metastatic disease
- •cT4 (Skin or muscle involvement) or Paget's disease of the nipple
- •Patients undergoing mastectomy
- •Patients undergoing neoadjuvant systemic therapy
- •Connective tissue disease or scleroderma, contraindicating radiotherapy
结局指标
主要结局
Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.
时间窗: 5 years
The BREAST-Q is a validated patient-reported outcome measure of breast related satisfaction and quality of life, including psychosocial, sexual well-being, and physical domains. Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.
时间窗: 5 years
Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale
时间窗: 5 years
Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.
时间窗: 5 years
Data for perioperative complications will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
次要结局
- Effectiveness of partial mastectomy with IORT, measured by local recurrence.(5 years)
- Effectiveness of partial mastectomy with IORT, measured by regional recurrence.(5 years)
- Effectiveness of partial mastectomy with IORT, measured by distant recurrence.(5 years)
- Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.(5 years)
- Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.(5 years)
- Effectiveness of partial mastectomy with IORT, measured by overall survival(5 years)
研究者
Janie Grumley
Director, Margie Petersen Breast Center; Associate Professor of Surgery, Saint John's Cancer Institute
Saint John's Cancer Institute