NCT03936478招募中2 期
A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Physician Reported Cosmesis: 1-year
研究概览
简要总结
This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •For all participants
- •Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
- •Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
- •Pregnancy test negative in women of child bearing potential (WOCBP).
- •The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
- •Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- •For participants with Invasive Carcinoma
- •Suitable:
- •Age: >=50 years
- •Margins: Negative by at least 2 mm
- •T Stage: Tis or T1
- •Cautionary:
- •Age: 40-49 years
- •Margins: Negative by at least 2 mm
- •T Stage: Tis or T1 OR
- •Age: >=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)
- •Pathologic Factors:
- •Size 2.1-3.0 cm (size of the invasive component)
- •Close margins (<2 mm)
- •Limited/focal Lymphovascular Space Invasion (LVSI)
- •Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).
- •Invasive lobular histology
- •Extensive Intraductal Component (EIC) <=3 cm
- •For participants with DCIS
- •Suitable Criteria, DCIS allowed if all of the following are met:
- •Screen-detected
- •Low to intermediate nuclear grade
- •Size <=2.5 cm
- •Resected with margins negative at >=3mm OR
- •Cautionary Criteria:
- •Pure DCIS <=3 cm if "suitable" criteria not fully met
排除标准
- •(unsuitable criteria) :
- •Men are not eligible for this study.
- •BRCA1/2 mutation positivity.
- •Age < 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).
- •Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).
- •Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- •Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).
- •Pure DCIS >3 cm in size (ASTRO Unsuitable Criteria).
- •Presence of extensive intraductal component >30mm (ASTRO Unsuitable Criteria).
- •Paget's disease of the nipple.
- •History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)
- •Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
- •Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.
- •Breast implants.
- •Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.
- •Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
- •Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.
研究组 & 干预措施
8.2 Gy Radiation Therapy
Experimental
Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.
干预措施: MRIdian Radiation Treatment Unit (Radiation)
结局指标
主要结局
Physician Reported Cosmesis: 1-year
时间窗: up to 1-year
The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.
次要结局
- Physician Evaluated Fat Necrosis(up to 5 years)
- Physician Reported Cosmesis: 3-year(up to 3 years)
- Participant Quality of Life: Convenience of Care Scale(up to 5 years)
- Participant Quality of Life: BCTOS Survey(up to 5 years)
- Participant Quality of Life: MOS SF-36 Survey(up to 5 years)
- Acute Radiation Toxicity(up to 90 days from completion of radiation therapy)
- Late Radiation Toxicity(up to 5 years)
- Ipsilateral Breast Tumor Recurrence (IBTR)(up to 5 years)
- Ipsilateral Regional Nodal Recurrence(up to 5 years)
- Disease Free Survival (DFS)(up to 5 years)
- Overall Survival (OS)(up to 5 years)
研究者
研究点 (2)
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