跳至主要内容
临床试验/NCT00351962
NCT00351962已完成不适用

Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours

AHS Cancer Control Alberta2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2006年9月最近更新:
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
58
试验地点
2
主要终点
Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5.

研究概览

简要总结

Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.

详细描述

You will be positioned in a special body mould while you are lying in the treatment position. This ensures that you are treated in the exact position each time. A soft plastic sheet may be placed over your body from the chest down. A vacuum device may be used to apply the sheet gently over you. This mild compression will ensure that you can breathe comfortably but will minimize any movement which may affect the accuracy of your treatments.

A CT (computed tomography) scan will be done for your treatment planning. The CT scan will take approximately 45 minutes. In some cases, intravenous dye may be administered during the CT scan. You will be asked to hold your breath for a short time during the CT scan. If you are unable to hold your breath comfortably, the scan will be performed during your normal breathing cycle. In some cases, your doctor may also order a PET (positron emission tomography) scan. The treatment planning to be done by your oncologist and physicist will take approximately one to two weeks. After that is completed, your treatments will begin. Each treatment will take about 30 minutes.

If the CT scans show that there is a lot of movement of your lung cancer due to breathing motion, your oncologist may recommend the insertion of a "fiducial" marker to help guide your treatments. An additional consent form will be obtained prior to this procedure. The "fiducial" marker is a tiny gold or stainless steel coil measuring about one inch long. It would be inserted into your lung in or next to the tumour by a respirologist via bronchoscopy under sedation. The procedure would take approximately 30 minutes, and you would be in hospital for about 4 hours. You would meet the respirologist in the clinic in consultation prior to the procedure so that he/she can tell you more about the procedure and assess your case in details to determine if it is safe for you to undergo the procedure. The insertion of the fiducial marker is considered part of your clinical care and a separate consent will be required prior to this procedure. You may choose not to undergo this procedure but still participate in this study. In some cases, your respirologist may have already inserted a fiducial marker at the time of diagnostic bronchoscopy after discussions with yourself and your radiation oncologist. The "fiducial" marker would be used to guide your radiation treatments during your normal breathing cycle.

You will be assigned into one of the two study groups described below depending on the location of your tumour:

Schedule I (10 fractions): You will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • non-small cell lung cancer less than 6cm; no mediastinal or distant metastases
  • Open to Alberta,Canada Residents

排除标准

  • tumour size greater than 6cm; inadequate pulmonary function(ie. FEV1 less than 0.8 L), Karnofsky performance status less than 70, multiple co-morbid conditions

研究组 & 干预措施

Schedule II (4 fractions)

Experimental

Subjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.

干预措施: Fractionated Stereotactic Radiotherapy (Procedure)

Schedule I (10 fractions)

Experimental

Subjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.

干预措施: Fractionated Stereotactic Radiotherapy (Procedure)

结局指标

主要结局

Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5.

时间窗: At the completion of accrual, an analysis with respect to acute toxicity will be performed after all patients have been followed a minimum of 90 days from the start of RT.

Each schedule will be evaluated according to the occurrence of DLTs observed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验