Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants accrued
研究概览
简要总结
Partial Breast Irradiation (PBI) is a targeted radiation approach commonly administered post-lumpectomy, specifically targeting the tumour bed. This targeted therapy reduces the exposure to other nearby tissues such as lungs, heart, and chest wall. However, traditional PBI treatment involves lengthy multiple fraction courses which presents a burden to patients from rural and remote communities, who must travel long distances to receive high quality cancer care. The purpose of this study is to compare single fraction (SF) PBI vs. multiple fraction (MF) PBI.
详细描述
Radiation can be delivered in multiple fractions, or doses, and can take up to several weeks or months of treatment depending on the type of cancer. Radiation can also be offered in a single fraction. Both techniques have evidence for use in clinical care. Multiple fraction is offered to reduce the amount of radiation given at a single time that could reduce late toxicities. However, single fraction radiotherapy is more cost-effective and saves patient time. With this trial, we will compare single fraction vs. multiple fraction PBI in regards to their impact on quality of life, rates of provider and participant reported toxicities, and local control.
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
- Single (Outcomes Assessor)
盲法说明
This will is an open-label randomized controlled study design, however, outcome assessors and data analysts will be blinded to the identity of each treatment arm.
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
- •Female participants age 40 or older
- •Able to provide informed consent
- •pTis-2 pN0 cM0 breast cancer, with tumor size <3 cm as per provincial guidelines
- •Able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver/family/friend/research staff
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •A history and physical (clinical breast) examination, including ECOG performance status, performed within 8 weeks prior to enrollment.
- •Participant is judged able to:
- •Maintain a stable position during therapy
- •Tolerate immobilization device(s) that may be required to deliver PBI safely
- •Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date
排除标准
- •History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
- •Uncontrolled concurrent malignant cancer
- •Seroma not visible
- •Ipsilateral implanted cardiac device
- •Prior radiotherapy requiring summation for planning.
- •Requirement for a radiation boost (as determined by the treating investigator)
- •Positive surgical margins
- •Surgical cavities lacking clear delineation (surgical clips are not required but may assist in target delineation)
- •Known germline BRCA1/2 mutation.
- •Serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)
- •Pregnant or breastfeeding
研究组 & 干预措施
Multiple Fraction PBI (Arm 1)
For participants randomized to Arm 1, PBI will be delivered with a dose of 26 Gy in 5 daily fractions.
干预措施: Multiple Fraction PBI (Radiation)
Single Fraction PBI (Arm 2)
For participants randomized to Arm 2, PBI will be delivered in a single fraction with a dose of 13 Gy.
干预措施: Single Fraction PBI (Radiation)
结局指标
主要结局
Number of participants accrued
时间窗: 2 years
Number of participants who sign consent to be randomized to 1 vs 5 fractions of radiotherapy for PBI over a 2 year period
Number of participants accrued
时间窗: 2 years
Number of participants who sign consent to be randomized to 1 vs 5 fractions of radiotherapy for PBI over a 2 year period
次要结局
- Progression-Free Survival (PFS)(6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months)
- Overall Survival (OS)(Approximately at the end of year 2 (study completion))
- Time from CT simulation to plan approval(Baseline)
- Rates of provider-rated toxicities: Occurrences of adverse events as measured by CTCAE(Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment)
- Overall Survival (OS)(Approximately at the end of year 2 (study completion))
- 2-Year Local Control Rates(6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment)
- Participant-reported toxicities(Baseline, 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment)
- Progression-Free Survival (PFS)(6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months)
- Quality of life assessed using the POSI-Breast questionnaire(Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment)