A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for stage I/II breast carcinoma: Initial report of feasibility and reproducibility of radiation therapy oncology group (RTOG) study 0319

A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for stage I/II breast carcinoma: Initial report of feasibility and reproducibility of radiation therapy oncology group (RTOG) study 0319
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DOI:
10.1016/j.ijrobp.2005.06.024
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发表时间:
2005-12-01
影响因子:
7
通讯作者:
McCormick, B
McCormick, B
中科院分区:
医学1区
文献类型:
--
作者:
Vicini, F;Winter, K;McCormick, B

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背景资料:本前瞻性研究(放射治疗肿瘤组研究0319)检查了三维适形外射束放射治疗在加速部分乳腺照射中的应用。再现性,作为衡量的技术可行性,是主要的终点,目的是证明该技术是否广泛适用于多中心设置之前的第三阶段trials.Methods和材料:这项研究的目的是,如果少于5例的第一个42名患者评价被评为不可接受的,治疗将被认为是可再现的。患者接受38.5戈伊,3.85戈伊/次,每日两次。临床靶体积包括肿瘤切除术腔加上皮肤表面和肺胸壁界面内5 mm的10 - 15 mm边缘。计划靶体积(PTV)包括临床靶体积加上10 mm边缘。治疗计划的判断如下:(1)无变化(总覆盖率),95%等剂量面覆盖100%的PTV,符合所有规定的临界正常组织剂量-体积直方图(DVH)限值。(2)微小变化(边缘覆盖),95%等剂量面覆盖率在>= 95%和3%之间
Background: This prospective study (Radiation Therapy Oncology Group Study 0319) examines the use of three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Reproducibility, as measured by technical feasibility, was the primary end point with the goal of demonstrating whether the technique is widely applicable in a multicenter setting before a Phase III trial is undertaken.Methods and Materials: This study was designed such that if fewer than 5 cases out of the first 42 patients evaluable were scored as unacceptable, the treatment would be considered reproducible. Patients received 38.5 Gy in 3.85 Gy/fraction delivered twice daily. The clinical target volume included the lumpectomy cavity plus a 10-15-mm margin bounded by 5 mm within the skin surface and the lung-chest wall interface. The planning target volume (PTV) included the clinical target volume plus a 10-mm margin. Treatment plans were judged as follows: (1) No variations (total coverage), 95% isodose surface covers 100% of the PTV and all specified critical normal tissue dose-volume histogram (DVH) limits met. (2) Minor variation (marginal coverage), 95% isodose surface covers between >= 95% and 3