Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change from baseline in pulmonary function and heart function tests
研究概览
简要总结
Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. However the magnitude of the clinical advantage of using the system in breast cancer is unknown. The purpose of the present study is to investigate whether or not the Tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.
详细描述
Prior to surgery: histological confirmation; medical imaging.
Localizing markers are placed in case of breast conserving surgery.
After surgery, patients are randomized to one of two treatment arms:
- Arm I: radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure (Voordeckers M et al, Radiother Oncol 2003;68:227 and 2004;70:225). Dose-fractionation: 50 Gy in 25 fractions over 5 weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over 2 weeks if breast conserving surgery (verify marker/clip localization) and age <= 70 years.
- Arm II: radiotherapy using the Tomotherapy system. Target area (breast, thorax wall, nodal areas) delimited according to pre-operative imaging and pathological description. Dose-fractionation (adapted from Whelan T et al, JNCI 2002;94:1143): 42 Gy in 15 fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast conserving surgery.
Physics quality control is integrated during treatment in both arms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Histologically proven breast carcinoma
- •Stage I or II (T1-3N0 or T1-2N1 M0, AJCC/TNM 6th edition)
- •Surgery with clear margins
- •Pre-operative medical imaging (at least CT, MRI, and/or PET-scan)
排除标准
- •Prior breast or thoracic radiotherapy
- •Pregnancy or lactation
- •Fertile patients without effective contraception
- •Psychiatric or addictive disorders
结局指标
主要结局
Change from baseline in pulmonary function and heart function tests
时间窗: From end of treatment up to 3 years after treatment
Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment
次要结局
- Local-regional recurrences.(From end of treatment up to 15 years after treatment)
研究者
Vincent Vinh-Hung, MD, PhD
Clinical Professor
Vrije Universiteit Brussel