Postoperative Radiotherapy With Intensity-modulated Radiation Therapy (IMRT) Using Simultaneous Integrated Boost Versus 3-dimensional Conformal Radiotherapy (3D-CRT) in Early Breast Cancer: a Prospective Randomized Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 690
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
It has been not clinically determined whether TomoDirect was dosimetrically better than 3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer patients of an Asian cohort.
详细描述
In breast cancer patients, helical TomoTherapy is not a suitable option since the gantry continuously rotates around the patient, and this technique can deliver low dose radiation to lungs that is associated with an occurrence of radiation pneumonitis. To avoid this inefficiency of beam usage, a TomoDirect option using static gantry positions combined with simultaneous couch translation and dynamic collimator modulation has been developed. In a pilot study, TomoDirect seemed particularly well suited for postoperative irradiation in breast cancer patients. TomoDirect achieved an optimal target volume coverage and coincident adequate normal tissue sparing in a dosimetric study. Clinical studies of TomoDirect in breast cancer patients are scarce and have been assessed only in small and retrospective series. Thus, we undertook a prospective study on the technical feasibility and toxicity of TomoDirect in breast cancer patients who received postoperative radiotherapy.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •histologically confirmed breast cancer after breast-conserving surgery
- •no evidence of distant metastasis
- •no previous malignancy
- •patient age, 20 - 80 years
- •Karnofsky performance score ≥ 70
- •adequate bone marrow, liver, and renal function (leucocytes > 4,000/mm3, hemoglobin > 10 g/dL, platelets > 100,000/mm3; serum bilirubin < 1.5 mg/dL, serum transaminase < 2.5 times the upper normal limit; serum creatinine < 1.5 mg/dL).
- •completion of scheduled chemotherapy
排除标准
- •carcinoma in situ of breast
- •distant metastasis
- •both breast cancer
结局指标
主要结局
Disease-free survival
时间窗: 3-year
次要结局
- Toxicity(acute (time frame: with 3 months after radiation) and late (time frame: up to 3 years after radiation), Participants will be followed for an expected average of 3 years.)
研究者
Jong Hoon Lee
Professor
Seoul St. Mary's Hospital