A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
研究概览
简要总结
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
详细描述
This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •-Newly diagnosed Stage 0 or I breast cancer.
- •On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
- •Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
- •Age 50 years or greater
- •ER positive: (≥1% of breast tumor cells express ER in their nuclei)
- •PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei)
- •Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified)
- •Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
- •Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm
- •Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
- •No involved axillary lymph nodes, N0(i+) allowed
- •Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery.
- •Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT
- •Signed study-specific informed consent form
排除标准
- •-Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- •Patients with tumors greater than 2 cm
- •Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
- •Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
- •Patient with lymphovascular space invasion (LVSI).
- •Patients with involved axillary nodes.
- •Patients with collagen vascular diseases.
- •Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1)
- •Patients with prior ipsilateral breast irradiation.
- •Patients with prior ipsilateral thoracic irradiation.
- •Patients with Paget's disease of the nipple.
- •Patients with diffuse suspicious microcalcifications.
- •Patients with suspicious microcalcifications remaining on the post-excision mammogram.
- •Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
- •Patients with oncoplastic reconstruction and absence of surgical clips
研究组 & 干预措施
Treatment-Radiation
CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.
干预措施: CK Stereotactic Accelerated Partial Breast Irradiation (Radiation)
结局指标
主要结局
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
时间窗: Enrollment to 24 months
Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
Feasibility
时间窗: 2 years
How many patients were able to undergo CK SAPBI
次要结局
- Ipsilateral Breast Recurrence(1 month post radiation treatment through 5 years post treatment)