Randomized Clinical Trial Comparing Two Adjuvant Radiotherapy Hypo Fractionation Schedules In The Treatment of Post Mastectomy Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Chest wall pain
研究概览
简要总结
This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules (40 Gy /15 fx / 3 weeks, 5 days per week VS 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week) as adjuvant radiotherapy in female patients with breast cancer after mastectomy.
详细描述
166 patients of breast cancer patients after mastectomy ( 83 patients in each arm ) will be randomize into 2 hypofractionation arms : Arm A: 40 Gy /15 fx / 3 weeks, 5 days per week . Arm B: 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week.
Simulation:
Patient will be simulated on CT simulator using breast wedge with angle. Serials will be taken every 2 mm from upper neck down to mid abdomen.
Contouring:
CTVcw, CTVRNI will be contoured through RTOG guidelines . PTV is added as 0.5 cm all around CTV. Lungs, Heart, brachial plexus, spinal cord, esophageus and thyroid will be contoured as OAR. (www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive carcinoma of the breast.
- •Complete microscopic excision of primary tumour and axillary dissection or SLNB .
- •Females with locally advanced breast cancer ( T3/T4 or N + or both ) who are candidate for neoadjvant chemotherapy regardless pathological stage after mastectomy.
- •Patients with pathological stage (T3/ T4, +/- N+) or ( N+, any T) after upfront mastectomy.
- •Able to comply with follow up.
- •Written informed consent
排除标准
- •Patients do not match with inclusion criteria.
- •Collagen vascular disease, specifically systemic lupus, or scleroderma.
- •Pregnancy or lactation at the time of radiotherapy.
结局指标
主要结局
Chest wall pain
时间窗: 3 months form starting of Adjuvant radiotherapy to chest wall.
Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity.
Dysphagia
时间窗: 3 months form starting Adj radiotherapy to chest wall.
Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity.
Skin
时间窗: 3 months form staring adjvant radiotherapy to chest wal.
Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity.
Pulmonary Toxicity
时间窗: Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years.
Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity.
Lymphedema
时间窗: Assessment will be started 6 montha form ending adjuvant radiotherapy to chest wall and axilla then then Biannaully for 2 years.
Common Toxicity Criteria v.5 ( Arm volume at CC.Grading done according to Interlimb Volume Difference.Interlimb volume difference \> 30 % is considered Grade 3 Lymphedema) and Cheng scale ( To detect proportion of patients having moderate or severe lymphedema (Grade 》II)
Brachial plexopathy
时间窗: Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years.
Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity.
次要结局
- Local control(Annually after the end of chest wall irradiation for 2 years. ] must be confirmed by cytological/ histological assessment)
研究者
Momen Elsayed Hassan, MSc.
Assistant Lecturer of Radiation Oncology
National Cancer Institute, Egypt