A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
研究概览
简要总结
As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.
The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.
详细描述
As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.
The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.
Investigators seek to assess the rate of cutaneous toxicity, the rates of lymphedema determined by arm measurements and Grade 3 brachial plexopathy in patients receiving regional nodal irradiation, as well as local control, quality of life, and fatigue levels.
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
- — 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:
- •Prior Chemotherapy for Breast Cancer
- •Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)
- •Non-Caucasian Race
- •Less than or equal to 50 years of age
- •Requiring regional nodal irradiation without evidence of N3 disease
排除标准
- •Males will be excluded
- •Women who are pregnant or nursing a child may not take part in this study
结局指标
主要结局
Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
时间窗: Duration of Study (Up to 18 months)
Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.
Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline
时间窗: Duration of Study (Up to 18 months)
Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.
Number of Participants With Grade 3 Brachial Plexopathy
时间窗: Duration of Study (Up to 18 months)
Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome
次要结局
- Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)(Baseline, end of Follow Up (Up to 18 months) (up to 18 months))
- Change in Perceived Stress Scale (PSS) Score(Baseline, End of Follow Up (Up to 18 months))
- Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels(Baseline, Post Intervention (Up to 18 Months))
- Change in C - Reactive Protein (CRP) Levels(Baseline, Post Intervention (Up to 18 Months))
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Breast Appearance Satisfaction Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Soluble TNF Receptor 2 (sTNFR2) Levels(Baseline, Post Intervention (Up to 18 Months))
- Change in Interleukin (IL)-6 Levels(Baseline, Post Intervention (Up to 18 Months))
- Change in Multidimensional Fatigue Inventory (MFI) Score(Baseline, end of Follow Up (Up to 18 months))
- Change in Breast Pain Level(Baseline, End of Follow Up (Up to 18 months))
- Change in Tumor Necrosis Factor (TNF) - Alpha Levels(Baseline, Post Intervention (Up to 18 Months))
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Short Form-36 (SF-36) Health Survey Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Lent Soma Scale Patient Questionnaire Score(Baseline, End of Follow Up (Up to 18 months))
- Change in Radiated Breast Appearance Score(Baseline, End of Follow Up (Up to 18 months))
研究者
Mylin Torres, MD
Associate Professor
Emory University