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Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00888823
First received: April 27, 2009
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
 Radiation: Stereotactic Radiotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

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

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Local Control [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Stereotactic Radiotherapy
    Stereotactic Radiotherapy
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888823

Contacts
Contact: Zsolt Gabos, MD (780)432-8783 zsoltgab@cancerboard.ab.ca

Locations
Canada, Alberta
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada
Contact: Zsolt Gabos, MD     (780)432-8783     zsoltgab@cancerboard.ab.ca    
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact: Zsolt Gabos, MD     (780)432-8783     zsoltgab@cancerboard.ab.ca    
Principal Investigator: Zsolt Gabos, MD            
Sponsors and Collaborators
Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00888823     History of Changes
Other Study ID Numbers: 24541/ethics24761
Study First Received: April 27, 2009
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
Fractionated stereotactic radiotherapy
Medically inoperable
Image-guided radiotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013