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临床试验/NCT02497664
NCT02497664已完成不适用

Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Mean Hart Dose (MHD)

研究概览

简要总结

Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment of esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical resections, and consequently to improve the survival rates. Due to improved survival, it will become increasingly important to minimize the radiation-induced toxicity among long-term survivors.

In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is the standard treatment modality. However, the dose that can be safely applied to the tumour is limited by the risk of cardiac and pulmonary complications, which even led to decreased survival in a randomised study, when a higher tumor dose was administered [1].

Radiation induced pulmonary and cardiac toxicity are the most important late side effects after thoracic radiotherapy [2-4].

The aim of this study is to reduce the radiation dose of heart (and lungs) in order to reduce the toxicity risk.

In recent years, the active breathing control (ABC) technique has been introduced in the radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the heart. These patients are irradiated in the inspiration phase, in which the distance between the heart and the breast is largest, while the lungs extend.

Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For these patients the expiratory phase might theoretically be more beneficial to reduce the heart dose. However, the inspiration phase might be better for the dose to the lungs, which consequently allows cardiac dose reduction.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven esophageal cancer (adeno-, or squamous cell carcinoma) of the mid or distal esophagus or stage III NSCLC (any histological subtype).
  • Scheduled for external-beam photon radiotherapy with curative intention.
  • Age >= 18 years
  • Written informed consent.

排除标准

  • Serious respiratory distress
  • Noncompliance with any of the inclusion criteria.

结局指标

主要结局

Mean Hart Dose (MHD)

时间窗: At 6 weeks after start of radiation therapy

次要结局

  • Dose Volume Histogram (DVH) parameters of the heart(At 6 weeks after start of radiation therapy)
  • Mean Lung Dosis (MLD)(At 6 weeks after start of radiation therapy)
  • Internal Target Volume (ITV) margin (margin for breathing movement defined as ITV - Gross Tumor Volume (GTV))(At 6 weeks after start of radiation therapy)
  • Position of the heart in relation to the target volumes(At 6 weeks after start of radiation therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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