Department of Radiation Oncology, University of Heidelberg, INF 400, 69120, Heidelberg, Germany.
BMC Cancer. 2011 Jun 15;11:249. doi: 10.1186/1471-2407-11-249.
Radiation therapy is an essential modality in the treatment of breast cancer. Addition of radiotherapy to surgery has significantly increased local control and survival rates of the disease. However, radiotherapy is also associated with side effects, such as tissue fibrosis or enhanced vascular morbidity. Modern radiotherapy strategies, such as intensity modulated radiotherapy (IMRT), can shorten the overall treatment time by integration of the additional tumor bed boost significantly. To what extent this might be possible without impairing treatment outcome and cosmetic results remains to be clarified.
METHODS/DESIGN: The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized into two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor bed by integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and consecutive boost in 8 fractions to a total dose of 66.4 Gy.
Primary objectives of the study are the evaluation of the cosmetic results 6 weeks and 2 years post treatment and the 2- and 5-year local recurrence rates for the two different radiotherapy strategies. Secondary objectives are long term overall survival, disease free survival and quality of life.
ClinicalTrials.gov Protocol ID: NCT01322854.
放射治疗是乳腺癌治疗的重要手段。在手术基础上增加放射治疗可显著提高疾病的局部控制率和生存率。然而，放射治疗也会产生副作用，如组织纤维化或增加血管发病率。现代放射治疗策略，如调强放疗（IMRT），通过整合额外的肿瘤床加量，可以显著缩短整体治疗时间。在不影响治疗效果和美容效果的前提下，这种可能性有多大仍有待阐明。
方法/设计：IMRT-MC2 研究是一项前瞻性、双臂、多中心、随机 III 期临床试验，比较了在保乳手术后的乳腺癌患者中，采用调强放疗加整合加量与常规放疗加连续加量的治疗效果。将招募 502 名患者并随机分为两组：A 组患者接受 28 次分割的调强放疗，50.4Gy 照射乳房，64.4Gy 照射肿瘤床，通过整合加量；B 组患者接受 28 次分割的常规放疗，50.4Gy 照射乳房，8 次分割的连续加量，总剂量为 66.4Gy。
该研究的主要目标是评估治疗后 6 周和 2 年的美容效果，以及两种不同放疗策略的 2 年和 5 年局部复发率。次要目标是长期总生存率、无病生存率和生活质量。
ClinicalTrials.gov 方案 ID：NCT01322854。
