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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
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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Brief Summary:
A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: Stereotactic Radiotherapy Phase 1 Phase 2

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Radiation: Stereotactic Radiotherapy
    Stereotactic Radiotherapy

Outcome Measures
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Primary Outcome Measures :
  1. Local Control [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: One Year ]
  2. Quality of Life [ Time Frame: One Year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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