Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Non-small Cell Lung Cancer
Trial Information
Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
OBJECTIVES:
Primary Objectives
- To determine the efficacy of hypofractionated, image guided radiotherapy in treating
patients with lung tumours, with the primary outcome being local control at one year.
- To determine the toxicity of high dose, small field,hypofractionated radiotherapy to
the lung, based on the RTOG and CTCAE scales.
Inclusion Criteria:
- T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall
involvement only)
- Medically inoperable due to co-morbid conditions or patient preference for radiation
- adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40%
of predicted), as assessed by consulting radiation oncologist
- age greater than or equal to 18, and Karnofsky performance status greater than of
equal to 70
Exclusion Criteria:
- Presence of mediastinal metastases or distant metastases
- Life expectancy less than 1 year due to other co-morbid conditions
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local Control
Outcome Time Frame:
One Year
Safety Issue:
Yes
Authority:
Canada: Health Canada
Study ID:
24541/ethics24761
NCT ID:
NCT00888823
Start Date:
March 2010
Completion Date:
May 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Fractionated stereotactic radiotherapy
- Medically inoperable
- Image-guided radiotherapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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