跳至主要内容
临床试验/NCT03339531
NCT03339531已完成不适用

Definition of Fields Margins for Optimized 2D Radiotherapy of Prostate Carcinoma

IRCCS Azienda Ospedaliero-Universitaria di Bologna0 个研究点目标入组 20 人开始时间: 2015年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
new indications for 2D fields definition

研究概览

简要总结

Prostate cancer (CAP) is one of the most common malignancies in men, both in Western countries and developing countries. Radiation therapy (RT) is an important therapeutic option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades, with a progressive improvement of clinical outcome. However, in many countries the only treatment option is the traditional 2D technique based on standard simulation. The indications for field definition in this treatment are still based on expert's opinions. The aim of this analysis is to propose new indications for 2D fields definition based on three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP consecutively treated with RT in our center were identified. Patients underwent CT-simulation in supine position. Pelvic MRI images were fused with CT-simulation images. In this way, delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment plans were calculated using the box technique. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.

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
18 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • > 18 years
  • clinical T stage: cT2b, cT2c, cT3a, cT3b
  • informed consent
  • MRI of the pelvis

排除标准

  • > 79 years
  • prior surgery treatment for prostate cancer
  • prior pelvic radiotherapy
  • genetic syndromes of hyper-radio-sensitivity
  • chronic infiammatory bowel disease

研究组 & 干预措施

2D radiotherapy

Experimental

Patients with prostate cancer were treated with 2D-radiotherapy

干预措施: 2D radiotherapy (Radiation)

结局指标

主要结局

new indications for 2D fields definition

时间窗: through study completion, up to 10 months

Twenty patients with prostate cancer (CAP) were identified. Pelvic MRI images were fused with CT-simulation images to delineate prostate and seminal vesicles on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP with or without involvement of the seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV. For each patient, 8 treatment plans were calculated using box tecnhique: 2 treatment plans for each risk category were calculated by using a cobalt source or 10 MV photons. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 \> 95%), distances of the fields edges from a set of reference points were measured.

次要结局

未报告次要终点

研究者

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

Alessio Giuseppe Morganti

Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

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