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临床试验/NCT01647334
NCT01647334终止不适用

Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
2
主要终点
Tumor reduction

研究概览

简要总结

This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Willing to provide informed consent
  • ECOG performance status 0-2
  • Histologically confirmed non-small cell lung carcinoma
  • Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
  • Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation
  • Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist

排除标准

  • Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy
  • Prior history of lung cancer within 5 years
  • Prior thoracic radiation at any time
  • Metastatic disease
  • in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.
  • inability to attend full course of radiotherapy of follow-up visits
  • Pregnant or lactating women

研究组 & 干预措施

Shrinking Target Adaptive Radiotherapy

Experimental

Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

干预措施: Adaptive radiotherapy (Radiation)

结局指标

主要结局

Tumor reduction

时间窗: 2.5 years (end of treatment)

次要结局

  • Radiation pneumonitis rates(6 months, 12 months, 18 months, 24 months, 30 months (semi-annually))
  • Rate of tumor shrinkage(2.5 years (end of treatment))
  • Overall survival(2.5 years)
  • Change in lung dose(2.5 years (end of treatment))
  • Delivered doses(2.5 years (end of treatment))
  • Local control(2.5 years (end of treatment))

研究者

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

David Palma

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (2)

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