Ultrahypofractionated Versus Normofractionated Sequential Boost After Whole-breast Radiation Therapy in Patients Treated With Breast-conserving Surgery for Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
研究概览
简要总结
The ULTIMO trial is a monocentric, prospective, randomised controlled, open-label, phase III interventional clinical trial, with a non-inferiority design, in patients with breast cancer undergoing breast conservative treatment (BCT). After giving informed consent and verifying eligibility, data collection starts and patients will be randomized in one of the following treatment arms:
- Standard treatment arm: Breast Conserving Surgery (BCS) takes place, followed by the SoC hypofractionated Whole Breast Radiation Therapy (WBRT) and SoC normofractioned sequential boost (normSEB) of 10Gy over 5 fractions.
- Experimental treatment arm: Breast Conserving Surgery (BCS) takes place, followed by the SoC hypofractionated WBRT and experimental ultrahypofractionated sequential boost (ultSEB) of 6Gy in a single fraction.
The primary objective of the ULTIMO study is to assess whether the ultSEB RT boost protocol is non-inferior to the current SoC normSEB RT boost protocol. This assessment will be based on the cosmetic outcome of the breasts, while also taking into account quality of life (QoL), the frequency and intensity of (S)AEs of interest (breast pain and fibrosis), and oncological survival.
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
- •Breast cancer patients referred for WBRT + boost to the lumpectomy cavity
- •Patients ≥18y
- •Karnofsky Performance Score >70%, or ECOG <2
- •Life expectancy of more than 5 years
- •Invasive tumour free resection margins, defined as R0 resection on the pathology report
- •Written informed consent
排除标准
- •Previous contralateral breast cancer
- •Previous RT of the same breast or thorax.
- •Metastatic disease (M1)
研究组 & 干预措施
Standard treatment arm (SoC; Normofractionated boost RT)
In the control arm, the boost of the radiation therapy will be delivered according to the standard of care fractionation and dosage scheme. This consists of 5 fractions of 2Gy each, adding up to a total dose of 10Gy.
All other treatments are not considered to be study-specific and are performed according to the standard of care treatment for breast cancer.
干预措施: Standard of Care (SOC) - Normofractionated Sequential Boost Radiation Therapy (Radiation)
Experimental treatment arm (Hypofractionated boost RT)
In the experimental arm, the boost of the radiation therapy is delivered in a ultrahypofractionated scheme. This consists of a single fraction of 6Gy.
All other treatments are not considered to be study-specific and are performed according to the standard of care treatment for breast cancer.
干预措施: Experimental - UltraHypofractionated Sequential Boost Radiation Therapy (Radiation)