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临床试验/NCT00499057
NCT00499057Unknown2 期

Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study

University Of Perugia2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年8月最近更新:
适应症

试验速览

阶段
2 期
入组人数
150
试验地点
2
主要终点
cancer related deaths

研究概览

简要总结

Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).

详细描述

Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse. Implants are positioned during surgery or postoperatively, within 12 weeks. Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. Before post-operative implantation, all patients undergo a breast computed tomography (CT) scan to visualize and expand the excision cavity and obtain the planning target volume (PTV), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. Through virtual simulation with a 3D treatment planning system (TPS), we define the implant catheter position. After implantation, in all patients a breast CT scan checked implant geometry. On CT images transferred to a TPS the surgical cavity is outlined and expanded, the PTV defined, and inactive and active source lengths measured.CT-based 3D software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the PTV. Dwell positions are activated for each catheter, and inactive and active lengths defined.Prescribed dose was 85% of the basal dose. Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. A dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (V100 and V150) was obtained for each patient. DHI, defined as V150 - V100/ V100 (7), is recognized as the most suitable quality index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age > or = 40 years
  • ECOG performance status 0-2
  • T dimensions ≤ 2.5 cm
  • Negative surgical margins
  • Negative axillary lymph nodes
  • Suitable breast anatomy for implantation

排除标准

  • Age < 40 years
  • ECOG performance status > 2
  • T dimensions > 2.5
  • Positive surgical margins
  • Positive axillary lymph node
  • Infiltrating lobular histology
  • Significant areas of lobular carcinoma in situ
  • Paget's disease of the nipple
  • Extensive intraductal component (EIC)
  • Lymphovascular invasion
  • Multifocality (n) skin infiltration

结局指标

主要结局

cancer related deaths

时间窗: 6 months

local relapses

时间窗: 6 months

次要结局

  • quality of life(6 months)
  • cosmetic results(6 months)
  • toxicity(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Aristei

Full Professor of Rdaiotherapy

University Of Perugia

研究点 (2)

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