Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy
详细描述
Breast cancer is the most commonly diagnosed cancer in Australia. Radiotherapy to the breast, chest wall and regional lymph nodes for breast cancer after surgery can reduce the risk of local recurrence by 50% and reduce breast cancer mortality. Traditionally, radiotherapy is delivered in a large number of small doses i.e. 25 treatment sessions over 5 1/2 weeks. Another approach is to give a lower number of larger doses i.e. 15 sessions over 3 1/2 weeks (hypofractionated radiotherapy).
Several studies in Europe and Asia have investigated hypofractionated radiotherapy to the chest wall, breast and regional lymph nodes following surgery for breast cancer, and found that it is equally effective to standard treatment, with similar side effects. These two approaches have not been directly compared in Australia.
This trial is to compare these two approaches, to determine whether hypofractionated radiotherapy is better tolerated by patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients will be randomised to one of the arms and will be notified for the randomization results. Randomisation ratio 2:1 (hypofractionation : standard)
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
- •Age 18 years and older
- •ECOG performance status 0-2
- •Ability to understand and willingness to sign a written informed consent document
- •Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing
- •Managed with either mastectomy or breast conserving surgery
- •Suitable for radiation therapy to the breast/chest wall and regional lymph nodes
- •Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted
- •Neoadjuvant radiotherapy (reverse sequencing) accepted
- •Breast implants and expanders are accepted
- •Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated
- •Life expectancy minimum 10 years
- •Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment)
排除标准
- •Prior radiotherapy to the ipsilateral breast or chest wall
- •Pregnancy or lactation
- •Radiosensitivity syndrome
- •Permanent pacemaker/defibrillator within radiotherapy field
- •Oncoplastic surgery where boost volume unacceptable (clinician discretion)
- •Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)
研究组 & 干预措施
Hypofractionation Arm
40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight)
干预措施: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy (Radiation)
Standard /Conventional fractionation Arm
50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight)
干预措施: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy (Radiation)
结局指标
主要结局
Fatigue
时间窗: six weeks post radiation treatment
Changes in patient reported fatigue at six weeks post commencing radiotherapy compared to baseline fatigue score. Fatigue score is rated as fatigue that interfered with patients' normal daily activities from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome
次要结局
- Changes in patients' quality of life(first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years)
- Number of participants with acute radiation dermatitis in irradiated area(During treatment)
- Number of participants with ipsilateral arm lymphoedema(3 years post radiation treatment)
- Self reported acute & late radiation toxicities(first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years)
- Compare the indirect radiation therapy costs by 2 treatment arms(4 weeks post radiation treatment)
- Number of participants with ipsilateral arm range of motion(3 years post radiation treatment)
- Disease Recurrence(5 years from treatment)
研究者
A/Prof Susan Carroll
Associate Professor Susan Carroll
Royal North Shore Hospital