NCT04849871进行中（未招募）不适用
Evaluation of Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma - BreaStBRT
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Proportion of patients who are free of breast cancer in the treated breast (IBTR)
研究概览
简要总结
This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.
- •Negative histologic margins of partial mastectomy or re-excision specimen. The posterior margin is always considered widely negative if the partial mastectomy extended to the pectoralis fascia and there is no tumor on ink. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.[42]
- •Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive.
- •Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of APBI.
- •Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
- •Postmenopausal status.
- •Age ≥ 50 years at diagnosis.
- •Able to understand and willing to sign IRB-approved written informed consent document.
- •All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with the following stipulations: F_APBI may be delivered at any Siteman location. S_APBI treatment must occur at the main Siteman location at BJH and will be delivered on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit. Pre and post treatment care is allowed at any Siteman center.
排除标准
- •Presence of distant metastases.
- •Nonepithelial breast malignancies such as sarcoma or lymphoma.
- •Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- •Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- •Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
- •Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
- •Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
- •Paget's disease of the nipple.
- •Skin involvement, regardless of tumor size.
- •Unsatisfactory breast for APBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with APBI is technically problematic.
- •Partial mastectomy so extensive that the cosmetic result is fair or poor prior to APBI as determined by the treating physician.
- •Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
- •Time between final definitive breast surgical procedures to APBI simulation is greater than 8 weeks.
研究组 & 干预措施
Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)
Experimental
-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)
干预措施: External Beam Accelerated Partial Breast Irradiation (Radiation)
Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)
Experimental
-External Beam APBI 30 Gy in 5 fractions over 5 days.
干预措施: External Beam Accelerated Partial Breast Irradiation (Radiation)
结局指标
主要结局
Proportion of patients who are free of breast cancer in the treated breast (IBTR)
时间窗: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)
-IBTRs will be categorized as local (infield) if they occur within the prescription isodose volume, peripheral if between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume, and non-contiguous or extrafield if they are beyond the peripheral volume described above.
Feasibility of treatment regimen as measured by the ability to complete accrual to the trial in 3 years
时间窗: Through enrollment of all participants (estimated to be 3 years)
次要结局
- Presence of complications(From start of treatment through 5 years (estimated to be 5 years and 5 days))
- Proportion of patients who are free of breast cancer in the regional lymph nodes(Through 5 years after completion of treatment (estimated to be 5 years and 5 days))
- Proportion of patients who are free of distant disease(Through 5 years after completion of treatment (estimated to be 5 years and 5 days))
- Proportion of patients who are alive(Through 5 years after completion of treatment (estimated to be 5 years and 5 days))
- Change in quality of life as measured by EORTC QLQ-C30(Baseline, 6 months post-end of radiation therapy (RT), 12 months post-end of RT, 24 months post-end of RT, 36 months post-end of RT, 4 years post-end of RT, and 5 years post-end of RT)
- Change in quality of life as measured by EORTC QLQ-BR23(Baseline, 6 months post-end of radiation therapy (RT), 12 months post-end of RT, 24 months post-end of RT, 36 months post-end of RT, 4 years post-end of RT, and 5 years post-end of RT)
- Change in cosmesis as measured quantitatively by the Breast Retraction Assessment (BRA)(Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years))
- Change in cosmesis as measured quantitatively by the Percent Breast Retraction Assessment (pBRA)(Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years)
- Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (physician graded)(Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years)
- Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (patient graded)(Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years)
- Occurrence of mastectomy after completion of initial breast-conserving treatment(Through 5 years after completion of treatment (estimated to be 5 years and 5 days))
- Frequency of any CTCAE v5.0 grade 3-4 toxicities(From start of treatment through 5 years (estimated to be 5 years and 5 days))
- Proportion of patients who are free of acute serious treatment related toxicity(From start of treatment until 6 months post-treatment (estimated to be 6 months))
- Proportion of patients who are free of late serious treatment related toxicity(From 6 months through 5 years (estimated to be 4.5 years))
研究者
研究点 (1)
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