Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00888823 |
Recruitment Status
:
Completed
First Posted
: April 28, 2009
Last Update Posted
: March 16, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Radiation: Stereotactic Radiotherapy | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | June 2014 |

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Radiation: Stereotactic Radiotherapy
- Local Control [ Time Frame: One Year ]
- Toxicity [ Time Frame: One Year ]
- Quality of Life [ Time Frame: One Year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888823
Canada, Alberta | |
Tom Baker Cancer Center | |
Calgary, Alberta, Canada | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada |
Responsible Party: | AHS Cancer Control Alberta |
ClinicalTrials.gov Identifier: | NCT00888823 History of Changes |
Other Study ID Numbers: |
24541/ethics24761 |
First Posted: | April 28, 2009 Key Record Dates |
Last Update Posted: | March 16, 2016 |
Last Verified: | March 2016 |
Keywords provided by AHS Cancer Control Alberta:
Fractionated stereotactic radiotherapy Medically inoperable Image-guided radiotherapy |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |